Who Is ATL?

Label Printer and ConverterMenomonee Falls, WI

Who Is ATL?

55 Year Old Company

Who Is ATL?

FDA RegisteredMedical Device Manufacturer

Who Is ATL?

cGMP Compliant to 21 CFR 210, 211, & 820

What makes ATL different?

Quality

What exactly is “Quality”?

Quality means conformance to requirements.

How is this done?

Through Quality Assurance

Quality Assurance at ATL

Six Sigma Black Belt Experience

Quality Assurance at ATL

Certified Security Personnel

Quality Assurance at ATL

Ongoing Systems Validation Protocol

Quality Assurance at ATL

Total Conformance: 2007 99.97%2008 99.98%2009 99.95%

Steps taken to ENSURE quality products…

Quality Management System

A capable and controlled (written) manufacturing

system.

Quality Management System

Failure Modes & Effects Analysis (FMEA)

FMEA is done through Internal and External Audits…

Internal Audit Process – Sample Job Flow

External Audits at ATL

ATL has successfully passed eighteen on-site ISO-9000 and cGMP compliance audits from pharmaceutical and medical companies since November 2000. Companies include:

NovartisBristol-Myers Squibb (BMS)Sanofi-Aventis Abbott Laboratories Pfizer

Johnson & Johnson Eli LillyGE MedicalSchering-Plough

Standard Operating Procedures…

SOP Sample

Written Control Plans…

Operation Description

Press / Machine / Device for Manufacture

Verif ication Mark and

Initials

Product / Process Specif ication Tolerance

Evaluation / Measurement Technique

Sample Size

Sample Freq.

Control Method / Data Recording Method

Reaction Plan

Incoming Material

NoneMaterials for Job

Inspect Compucal V-344Verify against

ATL P.O.

Per QMS

Sect. 8

ANSI Z1.4

C of A. Verify quantities, material type, w idth, etc. Check for transit damage.

Quality NCCA

Press Set-up

Press Checked for Cleanliness

Cleaning InspectOil, ink, and other

contaminants cleaned and removed from press.

Visual N/APer Run

Visual check of press.Quality NCCA

Press Run

TBDLabels Must be Clean

Inspect Rev. 4 Quality. No ink, oil, or grease marks. Product

must be clean.Visual

Start, During, & End.

N/A VisualQuality NCCA

Press Run/ Finishing

Rew indNo

Labels Missing

Inspect

3" I.D. (non-shredding) plastic core height to be consistent w ith backing

height +.000 / -.100.

Caliper/ Visual

Start, During, & End.

N/A VisualQuality NCCA

Finishing Rew indReplace

ment Labels

Inspect

Replacement labels must be evenly

spaced & straight in placement.

VisualStart,

During, & End.

N/A VisualQuality NCCA

Finishing Press/ Rew indSplice Tape

InspectSplices w ithin roll shall not interfear w ith part or liner.

VisualStart,

During, & End.

N/AVisual.

Verify correct splice tape.

Quality NCCA

Press Run/ Finishing

Press/ Rew indITC *

Dimensions

Inspect

3.035 +/-.010 .950 +/-.010 .675 +/-.010

.400 +/-.010 .665 +/-.010 .160 +/-.010 .1525

+/- .0100

Kestral X Y Axis Unit

Start, During, & End.

N/A

Kestral X Y Axis Unit. Verify that all dimensions

w ith * are per specif ications.

Quality NCCA

Date Initiated 09-07-05

Item Description Film, Sealing, Cuvette, Universal (All characteristics are considered major; * = critical).

Characteristics Product Process

Greg Gilanyi, Donald Dobert, Ross Lemke, Mike O' Connell.

ATL Control Plan (Levels III - IV- V) Customer

Process Qualif ication Team Job # Notes Draw ing ABCD, Revision 2.

Written Control Plan Sample

ATL’s Available Services:

Brand Protection / Security

Track and Trace:

• Invisible Digital Forensic Marking• Mass Serialization• Custom Codes• 2D Barcodes

Plus….

Brand Protection / Security

Authentication/Tamper Indicating

The PocketSureTM reading device uses proprietary

algorithms configured by InkSure Technologies to detect

the hidden code or image. Each code is unique.

Covert Marking or Taggants in Ink or Varnish

Brand Protection / Security

Hidden Scrambled Indicia Technology

• Hidden indicia is encoded in layers or in the varnish.

• Easily incorporated into any design.

• Decoded with an optical lens, proprietary software, or iDetector Mobile Authentication Device. Example of printed

layers

Example of optical lens decoding hidden message

Supply Chain Management and Auditing

Loss Prevention Assistance

Medical

MedicalCustom Die Cutting and Printing;

Master Roll Distribution – Medical Tapes and Foams

MedicalIsland Placement

MedicalWound Care and Hydrogel Manufacturing

MedicalMaterial Lamination

MedicalCold Sealing, Pouching and Packaging

Engineering Services

• Personal and confidential

• Design for manufacturability and cost reductions

• Rapid and cost effective prototypes

Label Capabilities

Label CapabilitiesMulti-Panel Booklet Labels, 3-35 Pages

Label CapabilitiesWrap-Around Construction

for Small Cylinders

Other Label Capabilities

Scratch OffsCold Foil Printing

Piggyback ConstructionsPeel Cards

Product Identification Labels

What is it costing you not to use ATL?

ATL Medicalwww.atlco.com

Mike O’Connellmoconnell@atlco.com