E nsuring the Safety of P acy Pe Compounding Hazardous ...€¦ · Additional Educational Opportunities Coming in 2016 Web‐based activity ‐ Based on today’s live symposium (1.5

E

Pro

nsurinComp

otectivand C

Pr

ng thepoundve EquClosed

resented 50

Planne

e Safetding Hauipmed Syste

as a Midd0th ASHP M

www

d by ASHP Ad

ty of Pazardo

ent, Enem Dr

day SympMidyear C

w.ashpad

dvantage and

Pharmaous Drngineerug‐tra

posium anClinical M

MondN

dvantage

supported b

acy Perugs: P

ering Cansfer

nd Live WMeeting an

ay, Decemew Orlea

e.com/en

by an educatio

ersonnPersonContro

Devic

ebinar atnd Exhibi

mber 7, 2ns, Louisi

nsuringsaf

onal grant fro

nel nal ols, ces

the tion

2015 iana

fety

om BD

Copyright © 2015, American Society of Health‐System Pharmacists, Inc. All rights reserved.

Please be advised that this activity is being audio and/or video recorded for archival purposes and, in some cases, for repurposing of the content for enduring materials.

Ensuring the Safety of Pharmacy Personnel Compounding Hazardous Drugs:

Personal Protective Equipment, Engineering Controls, and Closed System

Drug‐transfer Devices


Agenda

11:30 ‐ 11:35 a.m. Welcome and Introductions Thomas H. Connor, Ph.D. 11:35 ‐ 11:55 a.m. Keeping Personnel Safe: The Strong Case for Personal Protective Equipment Thomas H. Connor, Ph.D. 11:55 a.m. ‐ 12:15 p.m. Preventing Exposure to Hazardous Drugs: Role of Engineering Controls Eric S. Kastango, M.B.A., B.S.Pharm., FASHP 12:15 ‐ 12:40 p.m. Overview of the Vapor Performance Protocol for Closed System Drug‐transfer

Devices Deborah V.L. Hirst, Ph.D., P.E. 12:40 ‐ 1:00 pm Questions and Panel Discussion All Faculty

Faculty

Thomas H. Connor, Ph.D., Activity Chair Research Biologist National Institute for Occupational Safety and Health Cincinnati, Ohio Deborah V.L. Hirst, Ph.D., P.E. Senior Research Engineer Centers for Disease Control and Prevention National Institute for Occupational Safety and Health Cincinnati, Ohio Eric Kastango, M.B.A., B.S.Pharm., FASHP President/CEO Clinical IQ, LLC and CriticalPoint, LLC Madison, New Jersey

3





Disclosure Statement

In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support and the Accreditation Council for Pharmacy Education’s Standards for Commercial Support, ASHP Advantage requires that all individuals involved in the development of activity content disclose their relevant financial relationships. A person has a relevant financial relationship if the individual or his or her spouse/partner has a financial relationship (e.g., employee, consultant, research grant recipient, speakers bureau, or stockholder) in any amount occurring in the last 12 months with a commercial interest whose products or series may be discussed in the educational activity content over which the individual has control. The existence of these relationships is provided for the information of participants and should not be assumed to have an adverse impact on the content.

All faculty and planners for ASHP Advantage education activities are qualified and selected by ASHP Advantage and required to disclose any relevant financial relationships with commercial interests. ASHP Advantage identifies and resolves conflicts of interest prior to an individual’s participation in development of content for an educational activity.

Faculty and planners report no financial relationships relevant to this activity.

4





Activity Overview

In light of the ongoing process for improving the safety of pharmacy personnel during compounding and administration of hazardous drugs, this educational activity will explain the important role of personal protective equipment, including gowns and gloves, in preventing exposure to hazardous drugs. Current standards for testing glove permeation will be compared. Primary engineering controls will be reviewed with regard to reducing worker exposure to hazardous drugs. The activity will conclude with a review of the recently released National Institute for Occupational Safety and Health vapor containment performance protocol.

Learning Objectives

At the conclusion of this application‐based educational activity, participants should be able to

Explain the role of personal protective equipment, such as gloves and gowns, in the defense of healthcare workers exposure to hazardous drugs.

Compare the two current standards for testing chemical permeation of glove materials.

Review primary engineering controls on the basis of their ability to reduce worker exposure to hazardous drugs in the healthcare setting.

Review the recently released vapor containment performance protocol for closed system transfer devices.

Explain how closed system drug‐transfer devices reduce worker exposure to hazardous drugs.

Compare and contrast primary and secondary engineering controls used for the storage and compounding of hazardous drugs.

Additional Educational Opportunities Coming in 2016

Web‐based activity ‐ Based on today’s live symposium (1.5 hours of CPE, please note that individuals who claim CPE credit for the live symposium or webinar are ineligible to claim credit for the web‐based activity)

For more information and to sign up to receive e‐mail updates about this educational series, visit

www.ashpadvantage.com/ensuringsafety

5

Ensu

Per

Contin

education

Live Activ

On‐Dema

Complete

Webin

Visit www

Webi

Group

ring the Sa

sonal Prot

Copyrigh

nuing Ed

The AmeCouncil factivity p

n credit.

ity ACPE #: 02

nd Activity AC

e instructions

nar Infor

w.ashpadvant

nar registrati

p viewing info

afety of Ph

tective Equ

ht © 2015, Amer

ducation

erican Societyfor Pharmacyprovides 1.5 h

204‐0000‐15‐

CPE #: 0204‐0

for processin

rmation

tage.com/en

on link

ormation and

harmacy Pe

uipment, E

Drug‐tra

rican Society of H

n Accred

y of Health‐Syy Education ashours (0.15 C

‐481‐L03‐P

0000‐15‐481‐

ng continuing

n

suringsafety

d technical req

ersonnel C

Engineerin

ansfer Dev

Health‐System P

ditation

ystem Pharmas a provider oEUs – no part

‐H03‐P

education cr

to find:

quirements

Compound

g Controls

vices

Pharmacists, Inc.

acists is accreof continuing tial credit) of

redit online a

ding Hazar

s, and Clos

. All rights reserv

edited by the pharmacy edcontinuing p

re listed on th

dous Drug

sed System

ved.

Accreditationducation. Thisharmacy

he last page.

gs:

m

n s

6





Faculty

Thomas H. Connor, Ph.D. Research Biologist National Institute for Occupational Safety and Health Cincinnati, Ohio Dr. Connor is Research Biologist in the Division of Applied Research and Technology at the National Institute for Occupational Safety and Health (NIOSH). Dr. Connor received both his Bachelor and Master of Science degrees from the University of Rhode Island. He received his doctoral degree in Genetic Toxicology from the University of Texas Medical Branch. He was a member of the faculty of the University of Texas, School of Public Health in Houston for 20 years.

Dr. Connor is a primary contributor to the NIOSH Alert on Hazardous Drugs and is responsible for updating both the Alert and the list of hazardous drugs in the Alert. He is a member of the USP Chapter <800> Expert Panel and a member of the American Industrial Hygiene Association Hazardous Drug Working Group.

In 2008, Dr. Connor received the Award of Honor from the ASHP Board of Directors, which recognizes individuals outside the pharmacy discipline who have made extraordinary national or world‐wide contributions to the health field. In 2010, he received the International Society of Oncology Pharmacy Practitioners’ (ISOPP) Achievement Award for developing the ISOPP Standards of Practice for Safe Handling of Hazardous Drugs. His research has focused on occupational exposure to hazardous drugs in healthcare settings. Dr. Connor has published and lectured extensively on hazardous drug exposure topics.

7





Deborah V.L. Hirst, Ph.D., P.E. Senior Research Engineer Centers for Disease Control and Prevention National Institute for Occupational Safety and Health Cincinnati, Ohio Deborah V.L. Hirst, Ph.D., P.E., is Civil and Environmental Health Engineer with the Division of Applied Research and Technology, Engineering and Physical Hazards Branch. She is also a Lieutenant Commander in the U.S. Public Health Service.

Dr. Hirst received both her Bachelor of Science degree in civil and environmental engineering (2003) and her doctorate in environmental health engineering (2008) from the University of Alabama at Birmingham. Dr. Hirst joined NIOSH in 2007 and has researched and evaluated engineering control technology to reduce workers’ exposures to occupational safety and health hazards. Dr. Hirst’s work has included research on the following hazardous occupational air contaminants: diacetyl and other flavorings, formaldehyde, 1‐bromopropane (1‐BP), indium‐tin oxide, and hazardous drugs. She is a contributing author for the NIOSH criteria documents on diacetyl and 2,3‐pentandione, 1‐bromopropane, and glutaraldehyde.

Dr. Hirst’s research earned her Outstanding Unit Commendations as part of the larger Federal Emergency Management Agency temporary housing unit response effort. She also served as lead engineer for evaluating control technology for the Division of Respiratory Disease Studies indium‐tin oxide project. Two of Dr. Hirst’s current projects involve hazardous drugs. The first project is evaluating the efficacy of a Type C high‐efficiency particulate air filter for the capture and containment of select hazardous drugs within a controlled laboratory setting and real‐world hazardous drug compounding pharmacies. The second project for which she is co‐project officer is developing a protocol on closed‐system transfer devices for hazardous drugs.

8





Eric S. Kastango, M.B.A., B.S.Pharm., FASHP President/CEO Clinical IQ, LLC and CriticalPoint, LLC Madison, New Jersey

Eric S. Kastango, M.B.A., B.S.Pharm., FASHP, is president of Clinical IQ LLC, a health care consulting firm

and CriticalPoint, LLC, a web‐based education company.

Mr. Kastango received his Bachelor of Science degree in pharmacy from the Massachusetts College of Pharmacy and Allied Health Sciences and his Master of Business Administration degree from the University of Phoenix. He is also the 2014 recipient of the NABP Henry Cade Memorial Award that recognized the efforts and assistance to the states and NABP to address the compounding tragedy that occurred in 2012.

Since 1980, he has practiced pharmacy in a number of practice settings, including hospitals, community, and home care, in a number of different of roles, including the Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation. He has also managed a FDA‐registered cGMP manufacturing operation for Baxter Healthcare Corporation.

He is an active member and Fellow of the American Society of Healthcare Pharmacists and served on the USP Sterile Compounding Committee from 2005‐2010 and 2010‐2015 USP Council of Experts, Compounding Expert Committee until April 2013. He is currently an Expert Consultant to the USP and is actively working with NABP and state boards of pharmacy to provide training to their sterile compounding inspectors.

Eric is author of the 2004 ASHP Discussion Guide on Sterile Preparation: Summary and Implementation of USP Chapter 797, the ASHP Sterile Product Preparation CD‐ROM: A Multimedia Learning Tool, the ASHP web‐based 797 Compliance Advisor Gap Analysis Tool for USP Chapter 797 and the CriticalPoint web‐based educational series on Sterile Compounding and the Annual National USP <797> Compliance Survey now in its fourth year. Eric has over 200 invited national and international professional presentations on various pharmacy practice topics such as pharmacy compounding and quality systems.

9





10


Planned by ASHP Advantage and supported by an educational grant from BD

Thomas H. Connor, Ph.D., ChairResearch Biologist

Division of Applied Research and Technology

Deborah V.L. Hirst, Ph.D., P.E. Senior Research Engineer

National Institute for Occupational Safety and HealthCincinnati, Ohio

Eric S. Kastango, M.B.A., B.S.Pharm., FASHP

President and CEOClinical IQ, LLC and CriticalPoint, LLC

Madison, New Jersey

• Faculty and planners report no financial relationships relevant to this activity.

Disclosures

• Explain the role of personal protective equipment, such as gloves and gowns, in the defense of healthcare workers exposure to hazardous drugs.

• Compare the two current standards for testing chemical permeation of glove materials.

• Review primary engineering controls on the basis of their ability to reduce worker exposure to hazardous drugs in the healthcare setting.

• Review the recently released vapor containment performance protocol for closed system transfer devices.

• Explain how closed system drug‐transfer devices reduce worker exposure to hazardous drugs.

• Compare and contrast primary and secondary engineering controls used for the storage and compounding of hazardous drugs.

Learning Objectives

11


Keeping Personnel Safe: The Strong Case for Personal Protective

EquipmentThomas H. Connor, Ph.D.

Research BiologistDivision of Applied Research and Technology


The findings and conclusions in this report are those of the author and do not necessarily represent the views of the National Institute for Occupational Safety and Health (NIOSH). Mention of any company or product does not constitute endorsement by NIOSH. In addition, citations to Web sites external to NIOSH do not constitute NIOSH endorsement of the sponsoring organizations or their programs or products. Furthermore, NIOSH is not responsible for the content of these Web sites. All Web addresses referenced in this document were accessible as of the publication date.

Disclaimers

The New York Times, February 21, 2015

What’s wrong with this picture?

12


• Opaque bag cover suggests a chemotherapy drug

• No protective gown• No double gloves• No gloves at all• Working well above eye level

What’s Wrong with this Picture?

What is Personal Protective Equipment (PPE)?

“Personal protective equipment (PPE) refers to protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer's body from injury or infection.”

https://en.wikipedia.org/wiki/Personal_protective_equipment

Personal Protective Equipment

PPE is the least effective form of protection for workers

A. True

B. False

13


NIOSH Hierarchy of Controls


Not possible in healthcare


Not possible in healthcare

PPE is often the only protection

for some workers

14


• Gloves• Gowns• Respiratory protection• Eye and face protection• Sleeve covers• Shoe covers

PPE Used in Healthcare

• ASTM F739‐99a: Standard Test Method for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases Under Conditions of Continuous Contact

• ASTM D6978‐05: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

ASTM Permeation Test Standards

ASTM Standard Permeation Rate Temperature Drugs

F739 0.1 mcg/cm2/min Room (25 °C) None

D6978 0.01 mcg/cm2/min 35 ±2 °C 7 + 2 Optional

ASTM Permeation Standards

D6978 is based on F739 but is more stringent.

15


ASTM Standard Permeation Rate Temperature Drugs

F739 0.1 mcg/cm2/min Room (25 °C) None

D6978 0.01 mcg/cm2/min 35 ±2 °C 7 + 2 Optional

*Connor, TH: Unpublished data

ASTM Permeation Standards

Note: Permeation is directly proportional to temperature. Gloves reach about 35°C 5 minutes after donning

D6978 is based on F739 but is more stringent.

Required Drugs for Permeation Testing Using ASTM D6978

Drug Concentration (mg/mL)

Carmustine (BCNU) 3.3

Cyclophosphamide 20

Doxorubicin HCl 2

Etoposide 20

Fluorouracil 50

Paclitaxel 6

Thiotepa 10

2 drugs selected by manufacturer Based on selected drugs

Required Drugs for Permeation Testing Using ASTM D6978

Drug Concentration (mg/mL)

Carmustine (BCNU) 3.3

Cyclophosphamide 20

Doxorubicin HCl 2

Etoposide 20

Fluorouracil 50

Paclitaxel 6

Thiotepa 10

2 drugs selected by manufacturer Based on selected drugs

Note: Carmustine permeates most materials in a short time.

16


• Any material that passes ASTM 6978 can be used with chemotherapy

• Latex ‐ concerns over latex allergy• Nitrile ‐ some components of nitrile gloves may cause sensitivity

Glove Materials

Glove Materials

• Neoprene, polyurethane, blends available• Sterile chemotherapy gloves should be used in a biological safety cabinet

• Thin, vinyl exam gloves offer no protection against permeation

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

10000

11000

12000

0 30 60 90 120 150 180 210 240

ppb (n=3)

*Connor, TH: Unpublished data ppb = parts per billion

Cyclophosphamide Permeation at 37 °C with Polyvinyl Chloride Gloves*

MinutesMinutes

17


• American Society of Health‐System Pharmacists• National Institute for Occupational Safety and Health

• Oncology Nursing Society• Occupational Safety and Health Administration

U.S. Organizations that Recommend Double Gloving

Double Gloving

http://ehs.columbia.edu

• Offers more protection from

permeation

• More importantly, provides a “clean” glove after removing outer glove

• No comparable permeation test standard for protective gowns

• Some manufacturers using the same drugs as recommended for ASTM D6978

• May be using parameters from F739, which are less stringent

Protective Gowns

18


Protective Gowns

• Should be non‐linting and splash resistant• Should be removed carefully so that contamination is not spread

• Should not be reused

NIOSH, 2004

Protective Gowns

• Should be non‐linting and splash resistant• Should be removed carefully so that contamination is not spread

• Should not be reused*

Photo: Luci Power, Power Enterprises

*Note: Permeation continues when gown is hung up.

Respiratory Protection

• Should be used when engineering controls are not available or are inadequate

• Should always be used for spill cleanup• Must comply with OSHA regulations CFR 1910.134 (“Fit testing”)

OSHA = Occupational Safety & Health Administration

19


• Surgical masks ‐ offer no protection for worker, but help to maintain sterility of products

• N‐95/N‐100 ‐ offers protection from particulates, but not vapors



• Chemical cartridge half mask should be used to clean up “large” spills

• Powered air purifying respirators (PAPRs) can be used for cleaning up “large” spills

NIOSH 2009; http://www.grainger.com

• Should be used when exposure from splashes or spills is possible (e.g., bladder instillation)

• Safety glasses with side shields do not offer adequate protection from splashes or spills

• Safety goggles and/or face shields should be used as determined by procedure

NIOSH 2009; http://www.osbornemedicalsupply.com/

Eye and Face Protection

20


Sleeve Covers and Shoe Covers

• Sleeve covers offer some protection for an area that may come in contact with drug residue

• Shoe covers are required for cleanrooms and to help to stop spread of drug residues from being transported around facility

Disposal of Used PPE

• Typically disposed of as “Trace Waste”

Disposal of Used PPE

• Typically disposed of as “Trace Waste”

21


Which is the approved ASTM standard for glove testing?

A. F739

B. D6978

C. Either F739 or D6978

D. Neither F739 nor D6978

Which glove material should not be used when handling chemotherapy drugs?

A. Vinyl

B. Nitrile

C. Latex

D. Neoprene

• Key Takeaway #1 ‐ PPE should not be the first line of protection, but that is often the case.

• Key Takeaway #2 ‐ PPE should be one component of a comprehensive safety program.

• Key Takeaway #3 ‐ Proper donning, use, and removal of PPE can minimize worker exposure to chemotherapy and other hazardous drugs.

Key Takeaways

22


Preventing Exposure to Hazardous Drugs: Role of Engineering Controls

Eric S. Kastango, M.B.A., B.S.Pharm., FASHP President and CEO

Clinical IQ, LLC and CriticalPoint, LLCMadison, New Jersey

• I would like to thank Jim Wagner and CriticalPoint, LLC for the use of many of these slides.

• I am speaking in my individual capacity and not as a representative of any organization or committee regardless of my status, membership, or affiliations with any entity.

• The views and opinions presented are entirely my own. – They do not necessarily reflect the views of any other organization I may be associated with, nor should they be construed as an “official” explanation or interpretation of any USP chapter or any State Board of Pharmacy rule or law.

Acknowledgement and Disclosure

• At the end of this session, you will be able to– Distinguish between primary and secondary engineering controls in the sterile and nonsterile hazardous drug compounding controlled environments.

– Outline the different types of primary engineering controls used when performing nonsterile and sterile compounding.

Learning Objectives

23


Engineering Controls

• Engineering controls eliminate or reduce the potential exposure of a product or personnel to contamination or a hazard through the use of engineered equipment or machinery– Primary: Point of use– Secondary: Facility design

This is a picture of a secondary engineering control.

A. True

B. False

• Biological Safety Cabinet (BSC)• Compounding Aseptic Isolator (CAI) / Compounding Aseptic Containment Isolator (CACI)

Primary Engineering Controls Sterile Hazardous Drug Compounding

24


• Engineering controls employed in sterile compounding use Airflow through High Efficiency Particulate Air (HEPA) filters to create air of appropriate Cleanliness Classification– Airflow

– Filtration

– Cleanliness Classification

• Maintain a State of Control to obtain and confirm the Desired Outcome (Objective)

Engineering Controls

USP Chapter <797> requires the use of unidirectional HEPA filtered air inside primary engineering controls.

A. True

B. False

Airflow Definitions

• Unidirectional flow• Flow control to eliminate

particles from critical work sites

• HEPA‐filtered air should be supplied in critical areas at a velocity sufficient to sweep particles away from the compounding area and maintain unidirectional airflow during operations.

• Laminar vs. unidirectional

25


Improper hand placement disrupts first air

Photos: CriticalPoint, LLC

First Air

Proper hand placement takes advantage of first air


First Air (continued)

• Designed to provide worker protection and to provide an aseptic environment.

• If volatile drugs are prepared, the exhaust air from the isolator should be appropriately removed by properly designed building ventilation.

Compounding Aseptic Containment Isolators


Primary Engineering Controls

26


Compounding Isolators

CETA=Controlled Environment Testing Association CAG= Compliance Application Guide

• Compounding Aseptic Isolators must be placed in an ISO Class 7 cleanroom unless they meet all of the following conditions:– Must provide isolation from the

room

• Must maintain ISO class 5 duringdynamic operating conditions

• Transferring ingredients into andout of the isolator and duringpreparation of CSPs.

• Tests to prove above conditionsare detailed in CETA CAG‐002‐2006

• Isolators may be located in either a classified or anunclassified space

• Need to establish SOPs to reduce the chance ofbringing contamination into the isolator bycompromising the barrier

• Procedures will vary by isolator design(unidirectional vs. turbulent, pass‐through)– Ingress and egress of material– Recovery (purge) time– Cleaning and disinfection protocol

Isolator Work‐practice Considerations

“When asepsis is required or is the recommended work practice, the use of ventilated cabinets designed for both hazardous drug containment and asepsis is recommended”“The recommended ventilated cabinets include Class II Type B2, Class III BSC, and aseptic containment isolators”

Graphics: NIOSH

NIOSH Requirements For Hazardous Drug Primary Engineering Control Selection

Class II Type B2 BSC Class III BSC Negative Pressure CACI

27

See enlargement, p. 45


• Type A2 and B1 cabinets are allowed under certain conditions“A ventilated cabinet with air recirculation, either within the cabinet or to the room environment, should only be used if the hazardous drugs in use will not volatize during process manipulations or after capture by the HEPA filter”

NIOSH Requirements For Hazardous Drugs Primary Engineering Controls Selection

Graphics: NIOSH

• All C‐PECs used for manipulation of sterile HDs mustbe externally vented.

• Class II, Type A2, B1, B2, Class III BSC, and CACI areall acceptable.

• For most known HDs, Type A2 BSCs offer a simpleand reliable integration with the ventilation andpressurization requirements of the C‐SEC.– A2 BSC less exhaust airflow than B2– B2 BSC adds complexity and do not integrate well in smallrooms

– CACI risk contamination if leak in glove, sleeve, or cabinet

C‐PEC = Containment Primary Engineering Controls HD = Hazardous Drugs

Proposed USP <800> Requirements for Hazardous Drugs Primary Engineering Controls Selection

Primary Engineering Controls should not be turned off.

A. True

B. False

28



Primary Engineering Control User Suggestions

• Primary engineering controls should not be turned off– If turned off

• Requires recovery time• Must perform full daily cleaning

• Air‐balance of room for externally vented devices

• Pre‐filter change cycle– Cleanliness of room– Position of pre‐filter on device

• Understand the monitoring gauges– Magnehelic Gauge

• Containment Primary Engineering Controls (C‐PEC)– A ventilated device designed and operated to

minimize worker and environmental exposures to HDs by controlling emissions of airborne contaminant through:• Full or partial enclosure of potential contaminant source

• Use of airflow capture velocities to remove contaminants near the point of generation

• Use of pressure relationships that that define the direction of airflow into the cabinet

• Use of HEPA filtration on all potentially contaminated exhaust streams

• Examples include Class I BSC, Class II BSC, CVE (Containment Ventilated Enclosure)

Graphic: Labconoco. Used with permission.

PECs for Non Sterile Applications (<800>)

CVE Applications (<800>)

Graphic: Labconoco. Used with permission.

• Single exhaust HEPA filter– Must be externally vented

• Double exhaust HEPA filter– Can be externally vented (preferred) or recirculated back to the room

– Should only be recirculated back to the room if the hazard does not change phase (volatilize) at room temperature

29


Photo: CriticalPoint, LLC

Non‐Sterile Compounding

Positive Pressure

PEC

Negative Pressure

C‐PEC

Containment

C‐PEC = Containment primary engineering control

• Containment secondary engineering control (C‐SEC): The C‐SEC is the room in which the C‐PEC is placed. It incorporates specific design and operational parameters required to contain the potential hazard within the compounding room.

• Containment segregated compounding area (C‐SCA): A type of C‐SEC with nominal requirements for airflow and room pressurization as they pertain to HD compounding.

Secondary Engineering Controls

30


Used with permission. Copyright 2015 Clinical IQ.

Optimal Facility Design



• Limitations:– Non‐sterile or sterile low and medium‐risklevel CSPs

– Maximum sterile BUD:12 hours

– C‐PEC:• BSC or CACI for sterile HDcompounding or

• Powder hood for non‐sterile HD


Sub‐optimal Facility Design

How is the non‐HD ISO Class 7 room protected from contamination?

31





Adapted from CETA Certification Guide for Sterile Compounding Facilities. CAG‐003‐2006‐11 and NSF/ANSI 49‐2012 and reviewed by Jim Wagner in March 2014.

Certification Reference Cards for LAFWs and BSCsTraditional Primary Engineering Controls

TEST LAFWBSC

(NSF International Criteria)

Placement of Primary Engineering Control

Placed in ISO Class 7 cleanroom; 0.02” w.c. positive w.c. or SCA

Placed in ISO Class 7 Cleanroom,0.01”w.c. negative to anteroom

Airflow Velocity Velocity 80 to 100 feet/minute 6‐12” from the filter

Down flow Velocity Profile and Face Velocity Tests

HEPA Filter Leak TestHEPA filters must be certified to be

free from leaks > 0.01% of upstream aerosol concentration

HEPA filters must be certified to be free from leaks > 0.01% of upstream aerosol concentration or aerosol penetration

not > 0.005% of upstream concentration for filters that cannot be scanned

Airflow Patterns Smoke Test

An observation using smoke to visualize airflow under dynamic operating conditions (with pharmacy staff compounding) to confirm laminarity of the air is undisturbed by compounding processes. Specific smoke pattern tests to ensure the device is functioning properly is also performed under “at rest” conditions.

Site InstallationAssessment Tests N/A

Verifies that the BSC is properly integrated into the facility testing airflow and sash alarms; interlocks and exhaust system performance

Non‐Viable Particle Counts

Particle counters capable of detecting 0.5 μm size particles are used to verify ISO Class 5 air conditions under dynamic operating conditions

Adapted from CETA Compounding Isolator Testing Guide. CAG‐002‐2006 and reviewed by Jim Wagner in March 2014.

Certification Reference Cards for IsolatorsIsolator Type Engineering Controls

Test CAI CACI

Placement of PECPreferably room/area devoted to

compoundingRoom certified to have at least 12 ACPH and be 0.01” w.c. negative to

adjacent room

Airflow VelocityMeasurement of actual airflow to manufacturer’s design intent. The main

chamber is expressed as a range of feet/min with a designated % uniformity.

Chamber Pressure Test

Determines that pass‐through and main chamber pressures adequate to provide isolator separation between main chamber and ambient spaces.

Pressure range determined by manufacturer.Site Installation

Assessment TestsTests to verify proper alarm function; pass‐through door interlock function;

and proper canopy or exhaust connection performance.

HEPA Filter IntegrityLeak Test

All HEPA filters in the secondary engineering controls are tested at each certification. Maximum allowable leakage is 0.01% of the upstream aerosol

concentration.Airflow Smoke

PatternTest

An observation using smoke to visualize airflow under dynamic operating conditions (with pharmacy staff compounding) to confirm laminarity of the air

is undisturbedPreparation Ingress

and Egress TestDetermine if the pass‐through system is capable of supporting material transfer while maintaining ISO Class 5 conditions during the transfer.


Particle counters capable of detecting 0.5 μm size particles are used to verify ISO Class 5 air conditions both at rest and during dynamic operating conditions.

• Your choice of primary engineering control should

be based on processes, with concessions given to protection of compounding personnel and

environment.

• Primary engineering controls must be properly integrated into the facility and certified to be

functioning correctly.

• The certification process should be interactive to assure the facility will provide adequate support to

your critical operation.

Key Takeaways

32


Overview of the Vapor Performance Protocol for Closed System Drug‐transfer

Devices

Deborah V.L. Hirst, Ph.D., P.E. Senior Research Engineer


• Kenneth R. Mead, NIOSH• Luci Power, Power Enterprises• Eric Kastango, Clinical IQ, LLC• Ronald Kovein, NIOSH• Dylan Neu, NIOSH• Jim Wagner, Controlled Environment Consulting

Contributing Authors

• The findings and conclusions in this report are those of the author(s) and do not necessarily represent the views of the National Institute for Occupational Safety and Health.

Disclaimer

33


Does your practice/hospital use closed system drug‐transfer devices (CSTDs)?

A. Yes

B. No

Have you used CSTDs outside of a biological safety cabinet?

A. Yes

B. Sometimes

C. No

D. I do not use CSTDs

• Mechanically prohibits the transfer of environmental contaminants into the system

and the escape of hazardous drug or vapor concentrations outside the system.

• Supplemental controls.

NIOSH [2004]. NIOSH alert: preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. Publication No. 2004‐165.

CSTD Definition

34


• Containment‐type– “Truly closed system”

– Gas, vapor, and aerosol containment

– Physical barrier

• Air‐cleaning technology– Charcoal filter, etc.

– Not covered in protocol

Types of CSTDs

• Syringe adaptor

Graphic Credit: Graeham Heil, CDC/NIOSH

Evaluated CSTD Components

• Vial adaptor



35


• i.v. port or Y‐site adaptor



• Bag or infusion adaptor



• Publish CSTD performance evaluation protocol• Application

– Prototype evaluation

– Product comparison evaluation

– Adoption for performance testing

Protocol Objectives

36


• Surrogate selection• Instrument performance specifications• Selection of commercially available CSTDs• Environmental test chamber• Test procedures

Protocol Contents

• Challenge agents as substitutes– Performance of engineering controls and work practice interventions

– Safe (non‐toxic)

– Similar manipulation– “No” or easily removed background concentrations

– Measurable at low concentrations

Surrogate Selection

• 70% Isopropyl alcohol (IPA)– Liquid when contained at room temperature

– Easy removal of background concentrations of IPA

– High vapor pressure– Easily detected

– Relatively non‐toxic

Surrogate Selection

37


• IPA detector– Accuracy of ± 10%

– Range up to 100 parts per million

– Minimum flowrate of 10 Liters/minute– Within factory‐level calibration period

Instrument Performance Specifications

Photo: CDC/NIOSH

Environmental Test Chamber

• Two tasks– Compounding

– Compounding and administration

• Each task repeated 4 times for each CSTD system

plus no CSTD• Protocol test data

– Performance threshold

Test Procedures

38


• Prepare 500 mL of 0.9% sodium chloride i.v. bag with 90 mL of 70% IPA using 45 mL transfers. Repeat 3 more times.


Task 1

• Prepare 45 mL of 70% IPA in 60 mL syringes for i.v. push and Y‐site administration. Repeat 3 more times.


Task 2

• For NIOSH test, data were kept “blind” for each test run and coded by NIOSH statistician

• Performance threshold– Can be measurable by IPA detector– Can be used as a performance report – NIOSH does not propose a specific threshold

• Selected value will vary by test circumstances

• In example, NIOSH used the LOQ

– [3.3 x Limit of Detection (for IPA detector) = 1 ppm]

ppm = parts per million

NIOSH [1995]. Guidelines for air sampling and analytical method development and evaluation. Publication No. 95‐117.

Protocol Test Data

39


* These values had actual real‐time concentration measurements below the instrument’s reported limits of detection (LOD) of 0.30 ppm. The previously described special rules for handling data below the instrument’s LOD were applied to these values.

Protocol Test Data

Analysis Variable: BG‐0max

TaskCSTD Device ID Number

Number of

BG‐0max

Observations

Mean of BG‐0max

Observations (ppm)

Lower 95%Confidence Limit

(ppm)

Upper 95%Confidence Limit

(ppm)

Standard Deviation (ppm)

1 1 4 0.25* 0.09 0.41 0.102 3 0.33* 0.19 0.48 0.063 4 8.8 5.4 12 2.14 4 8.9 ‐1.8 20 6.75 4 16 4.9 27 7.0

2 1 8 0.28* 0.18 0.37 0.122 6 0.25* 0.12 0.38 0.123 8 4.7 0.42 9.0 5.14 8 1.3 0.69 1.9 0.735 7 16 ‐3.5 35 21

• Key Takeaway #1– The protocol’s intent is to challenge a CSTD’s ability to function as a closed system. Nothing in, nothing out.

• Key Takeaway #2– The protocol can be used to compare containment‐type CSTDs, evaluate prototypes, and as a performance certification protocol.

Key Takeaways

Questions?

40


Which of the following practice changes do you consider to the be the most challenging to make in the practice setting?

A. Convene a team meeting to study your institution’s CSTD protocol and discuss

possible changes that would improve safety.

B. Inspect the chemotherapy gloves in use at your institution to determine whether

they pass permeation testing.

C. Inventory the personal protective equipment in use at your practice setting and

bring any deficiencies to the attention of your supervisor.

D. Identify the primary engineering controls in use at your practice setting and

make sure they are appropriate and functioning properly. Bring any deficiencies

to the attention of your supervisor.

E. Read the primary engineering controls certification reports and verify that they

were tested according to the CETA guidelines.

Take a moment to consider the practice changes listed below and make notes regarding follow‐up activities, changes you want to make, how you might engage the support of colleagues, potential barriers, etc.

1. Convene a team meeting to study your institution’s CSTD protocol and discuss possible changes that would improve safety.

2. Inspect the chemotherapy gloves in use at your institution to determine whether they pass permeation testing.

3. Inventory the personal protective equipment in use at your practice setting and bring any deficiencies to the attention of your supervisor.

4. Identify the primary engineering controls in use at your practice setting and make sure they are appropriate and functioning properly. Bring any deficiencies to the attention of your supervisor.

5. Read the primary engineering controls certification reports and verify that they were tested according to the CETA guidelines.

Pause and Reflect: Making Practice Changes

41


“When asepsis is required or is the recommended work practice, the use of ventilated cabinets designed for both hazardous drug containment and asepsis is recommended”“The recommended ventilated cabinets include Class II Type B2, Class III BSC, and aseptic containment isolators”

Graphics: NIOSH

NIOSH Requirements For Hazardous Drug Primary Engineering Control Selection

Class II Type B2 BSC Class III BSC Negative Pressure CACI

• Type A2 and B1 cabinets are allowed under certain conditions“A ventilated cabinet with air recirculation, either within the cabinet or to the room environment, should only be used if the hazardous drugs in use will not volatize during process manipulations or after capture by the HEPA filter”

NIOSH Requirements For Hazardous Drugs Primary Engineering Controls Selection

Graphics: NIOSH

42






• Limitations:– Non‐sterile or sterile low and medium‐risk level CSPs

– Maximum sterile BUD: 12 hours

– C‐PEC:• BSC or CACI for sterile HD compounding or

• Powder hood for non‐sterile HD

43



Sub‐optimal Facility Design

How is the non‐HD ISO Class 7 room protected from contamination?

Adapted from CETA Certification Guide for Sterile Compounding Facilities. CAG‐003‐2006‐11 and NSF/ANSI 49‐2012 and reviewed by Jim Wagner in March 2014.

Certification Reference Cards for LAFWs and BSCsTraditional Primary Engineering Controls

TEST LAFWBSC

(NSF International Criteria)

Placement of Primary Engineering Control

Placed in ISO Class 7 cleanroom; 0.02” w.c. positive w.c. or SCA

Placed in ISO Class 7 Cleanroom,0.01”w.c. negative to anteroom

Airflow Velocity Velocity 80 to 100 feet/minute 6‐12” from the filter

Down flow Velocity Profile and Face Velocity Tests

HEPA Filter Leak TestHEPA filters must be certified to be

free from leaks > 0.01% of upstream aerosol concentration

HEPA filters must be certified to be free from leaks > 0.01% of upstream aerosol concentration or aerosol penetration

not > 0.005% of upstream concentration for filters that cannot be scanned

Airflow Patterns Smoke Test

An observation using smoke to visualize airflow under dynamic operating conditions (with pharmacy staff compounding) to confirm laminarity of the air is undisturbed by compounding processes. Specific smoke pattern tests to ensure the device is functioning properly is also performed under “at rest” conditions.

Site InstallationAssessment Tests N/A

Verifies that the BSC is properly integrated into the facility testing airflow and sash alarms; interlocks and exhaust system performance


Particle counters capable of detecting 0.5 μm size particles are used to verify ISO Class 5 air conditions under dynamic operating conditions

44


Adapted from CETA Compounding Isolator Testing Guide. CAG‐002‐2006 and reviewed by Jim Wagner in March 2014.

Certification Reference Cards for IsolatorsIsolator Type Engineering Controls

Test CAI CACI

Placement of PECPreferably room/area devoted to

compoundingRoom certified to have at least 12 ACPH and be 0.01” w.c. negative to

adjacent room

Airflow VelocityMeasurement of actual airflow to manufacturer’s design intent. The main

chamber is expressed as a range of feet/min with a designated % uniformity.

Chamber Pressure Test

Determines that pass‐through and main chamber pressures adequate to provide isolator separation between main chamber and ambient spaces.

Pressure range determined by manufacturer.Site Installation

Assessment TestsTests to verify proper alarm function; pass‐through door interlock function;

and proper canopy or exhaust connection performance.

HEPA Filter IntegrityLeak Test

All HEPA filters in the secondary engineering controls are tested at each certification. Maximum allowable leakage is 0.01% of the upstream aerosol

concentration.Airflow Smoke

PatternTest

An observation using smoke to visualize airflow under dynamic operating conditions (with pharmacy staff compounding) to confirm laminarity of the air

is undisturbedPreparation Ingress

and Egress TestDetermine if the pass‐through system is capable of supporting material transfer while maintaining ISO Class 5 conditions during the transfer.


Particle counters capable of detecting 0.5 μm size particles are used to verify ISO Class 5 air conditions both at rest and during dynamic operating conditions.

* These values had actual real‐time concentration measurements below the instrument’s reported limits of detection (LOD) of 0.30 ppm. The previously described special rules for handling data below the instrument’s LOD were applied to these values.

Protocol Test Data

Analysis Variable: BG‐0max

TaskCSTD Device ID Number

Number of

BG‐0max

Observations

Mean of BG‐0max

Observations (ppm)

Lower 95%Confidence Limit

(ppm)

Upper 95%Confidence Limit

(ppm)

Standard Deviation (ppm)

1 1 4 0.25* 0.09 0.41 0.102 3 0.33* 0.19 0.48 0.063 4 8.8 5.4 12 2.14 4 8.9 ‐1.8 20 6.75 4 16 4.9 27 7.0

2 1 8 0.28* 0.18 0.37 0.122 6 0.25* 0.12 0.38 0.123 8 4.7 0.42 9.0 5.14 8 1.3 0.69 1.9 0.735 7 16 ‐3.5 35 21

45





Notes

46





Self‐assessment Questions

1. According to permeation standards from ASTM, which of the following statements is TRUE:

a. The temperature of gloves does not change within until approximately 15 minutes afterdonning.

b. Glove permeation is directly proportional to temperature.c. Glove permeation is indirectly proportional to temperature.d. Etoposide permeates most gloves in short time.

2. Which of the following statements regarding protective gowns is TRUE?

a. Should be non‐linting and splash resistant.b. Can be worn continuously for up to 17 hours without permeation.c. Permeation test standards can be used to compare protective gowns.d. Are not a recommended part of personal protective equipment.

3. Containment‐type CSTDs contain ________.

a. Gas and vapor.a. Aerosol.b. Gas, vapor, and aerosol.c. Vapor and mists.

4. The NIOSH CSTD protocol uses 70% isopropyl alcohol as the challenge agent because

a. It is a liquid when contained at room temperature.b. It is easily detected.c. It is relatively non‐toxic.d. All of the above.

5. Which of the following statements is FALSE?

a. Primary engineering controls are point of use equipment that eliminate or reduce the potentialexposure of a product or personnel to contamination or a hazard.

b. Secondary engineering controls are facility designs that eliminate or reduce the potentialexposure of a product or personnel to contamination or a hazard.

c. USP Chapter <797> does not require the use of unidirectional HEPA filtered air inside primaryengineering controls.

d. Primary engineering controls should not be turned off.

47





6. Which of the following statements is FALSE regarding the operation of a primary engineering control?

a. Running 24/7 maintains the recirculation of HEPA filtered air. b. Unidirectional airflow flowing through the work chamber keeps the critical work area clean. c. Both single exhaust HEPA filter units and double exhaust HEPA filter units must be externally

vented, and cannot be recirculated back to the room. d. Turning off the exhaust blower changes the room air balance, typically, changing a negative

pressure containment room to positive pressure.

Answers

1. b 2. a 3. c 4. d 5. c 6. c

48

Ensu

Per

CE Ins

Per ACPE,activity orportal aremonth, aninformatio

For Mid

1. Log into regclaim

2. Click o

3. Enter

4. Click C

5. Comp

6. Once

7. Reviethe bo

For Offs

1. Log inwith A

2. Enter Redee

activit

3. Comp

Activity D

ring the Sa

sonal Prot

Copyrigh

struction

, CPE credit mr completion e reported dirnd birth day. on and applic

dyear Atte

n to the ASHPgister for the credit.

on Process CE

the attendan

Claim for any

plete the eval

all requireme

w the informottom and cli

site Webin

n to the ASHPASHP, use the

the enrollmeem. The title ty title.

plete all requi

N

Date: Mond

afety of Ph

tective Equ

ht © 2015, Amer

ns

must be claimeof a home‐sturectly to CPE MIf you do not cation.

ndees in N

P eLearning PoMidyear. The

E for the Mid

nce code ann

y session.

uation.

ents are comp

ation for the ick Claim. You

nar Attend

P eLearning Poe Register link

ent code annoof this activit

red elements

NEED HELP

day, Decemb

harmacy Pe

uipment, E

Drug‐tra

rican Society of H

ed no later th

udy activity. AMonitor. To chave an NAB

New Orlean

ortal at elearne system valid

year Clinical

ounced durin

plete (indicat

credit you aru will see a m

dees

ortal at elearnk to set up a f

ounced durinty will appear

s. Go to step s

P? Contact

er 7, 2015

ersonnel C

Engineerin

ansfer Dev

Health‐System P

han 60 days fAll ACPE‐accrclaim credit, yBP e‐Profile ID

ns

ning.ashp.orgdates your me

Meeting and

ng the session

ted with a gre

re claiming. Ifmessage if the

ning.ashp.orgfree account.

g the webinar in a pop‐up

six above.

eLearning

Code: _

Compound

g Controls

vices

Pharmacists, Inc.

rom the dateedited activityou must haveD, go to www.

g with the emeeting registr

d Exhibition.

n and click sub

een check ma

f all informatire are any pr

g/my‐activitie

ar in the Enro

box on your s

[email protected]

_ _ _ _

ding Hazar

s, and Clos

. All rights reserv

e of the live ties processede your NABP .MyCPEMonit

mail address aration to gran

bmit.

ark), click Clai

ion is correct,oblems claim

es. If you have

llment Code

screen. Click o

g

_ _ C

dous Drug

sed System

ved.

d on the eLeae‐Profile ID, btor.net for

nd password nt you access

m Credit.

, check the boming your cred

e never regist

box and clickon Go or the

CE Hours:

gs:

m

arning birth

used to

ox at dit.

tered

k

1.5

49

Documents

E nsuring the Safety of P acy Pe Compounding Hazardous ...€¦ · Additional Educational Opportunities Coming in 2016 Web‐based activity ‐ Based on today’s live symposium (1.5