TSB 2000010 Technical Overview of the STERILIZABLEBAG

5/27/2018 TSB 2000010 Technical Overview of the STERILIZABLEBAG

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Technical Support Bulletin 2000/010

11/7/08

Technical Overview of the STERILIZABLEBAG

I. Background

In pharmaceutical manufacturing, steam autoclave is the preferred sterilization technique for a widevariety of closures, packaging components and supplies including stoppers, seals, instruments andequipment. A method for packaging closures prior to sterilization and for maintaining sterility of

closures after autoclave treatment is the STERILIZABLEBAG. The bag is consideredenvironmentally friendly, heat sealable and a sterilizable protective package.

West Pharmaceutical Services (West) developed the STERILIZABLEBAGto meet market needs inEurope for the replacement of medical paper bags and in the United States for the replacement ofstainless steel containers. TYVEK

, a DuPont material globally recognized as a standard of

excellence for sterile packaging, is utilized for the STERILIZABLEBAG. TYVEK is speciallyengineered to enable steam to penetrate and escape quickly while providing a bacterial barrier and

high strength.

II. Product Description

The STERILIZABLEBAG is manufactured from two materials, TYVEK and high densitypolyethylene (HDPE), and is heat sealed on three sides. The bags are available in a standard400 mm X 500 mm size.

TYVEK material is spunbonded olefin produced from very fine continuous filaments of high densitypolyethylene bonded by heat and pressure, and contains no anti-static compounds, fillers oradditives. Both the TYVEK and HDPE comply with the United States Food and DrugAdministrations food packaging requirements and comply with regulations of most Europeancountries.

Since both sides of the bag are HDPE, and as such have similar chemical properties, there is highresistance to most acids, bases and salts. However, prolonged contact with strong acids and basesmay reduce physical strength and therefore should be avoided.

III. Attributes of TYVEK and HDPE

A. Particle Generation

Unlike medical paper, TYVEK and HDPE do not shed particles during shipment and processing.This quality makes both materials ideal for use in clean room environments. For example, intests using a tumbling apparatus, TYVEK generates far fewer particles as compared withstandard medical papers as reported by DuPont.

B. Liquid Resistance

TYVEK generally has approximately twice the resistance to liquid water penetration comparedwith standard medical papers. Even though resistant to liquids, TYVEK maintains highpermeation rates for gases and water vapor. Additionally, permeation properties as tested byGurley Hill Porosity (TAPPI T460 ISO 5636-5) are excellent and maintained even after steamsterilization up to 127 C.


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C. Puncture ResistanceTYVEK generally has between ten and twenty times the puncture resistance compared withvarious medical papers as reported by DuPont. This increased puncture resistance is an addedfeature in reducing the possibility of package penetration during rough handling and with contactof sharp objects such as metal caps and seals.

IV. Attributes of the STERILIZABLEBAG

A. Labeling

The STERILIZABLEBAGwill accept standard adhesive labels. Testing should be performed bythe customer on a per application basis to ensure that each type of label used adheres duringthe sterilization and processing cycles. Also care should be taken in location placement oflabels to prevent transfer of adhesive backing into the interior of the bag, which maycontaminate the contents. West recommends labeling on the HDPE side of bags.

B. Autoclave Indicator

Each bag contains an autoclave indicator that is a heat and humidity sensitive pigment and willchange color after a typical autoclave cycle.

C. Suggested Storage and Handling

Recommended storage is in the original sealed shipping container and under typicalpharmaceutical warehouse conditions.

V. STERILIZABLEBAGRecommendations

A. Heat Sealing

It is recommended that the heat seal be applied from the HDPE side at minimum 8 mm width.The following are recommended* starting setup parameters that can be used for validation ofthe heat seal:

Air Pressure: ~ 55 psig

Heat: ~ 212 C (forms seal)

Cool to ~ 65 C to open jaws

Dwell: ~ 2 seconds

The parameters listed will vary from model to model and must be validated.

*The recommended procedures are based on a Packworld Precision Heat Sealer,Model PW4024.


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B. Steam Sterilization

As TYVEK is high density polyethylene, the recommended sterilization processing temperatureis listed at 121.1 C under controlled conditions of vacuum and exhaust. The following points

should be considered for processing the STERILIZABLEBAG:

Autoclave with pure steam is essential.

Controlled evacuation rates are required to prevent bag heat seals from separating.Pressure rates of 3 psi/min have been shown to be successful.

Sterilization processing temperatures should not exceed 124 C or bags may be damaged.

Sterility and dryness of final product must be validated.

Bags should be placed on a perforated shelf, TYVEK side down and HDPE side up leavingspace around the bag to allow steam to circulate freely. (Note: If the autoclave shelves

are not perforated, the bag should be placed with the HDPE side down and the TYVEKside up.)

Autoclaving the bags will be different based on the size of the item, the number of items inthe bag and the type and size of the autoclave and its capabilities.

The following functions should be included: pre-vacuums, purges, sterilization not toexceed 124 C, post-vacuum and drying (if applicable).

To reduce the possibility of damaging the bags during the sterilization cycle, apreconditioning cycle with the following parameters is recommended. Using apressurization rate of 3 psi/min, pressurize the chamber to 40 psia reduce to 30 psia and

repeat 3 times. Using the same rate, reduce pressure to 2 psia and hold for 3 minutes.Proceed to your specific sterilization cycle but do not exceed pressurization/evacuationrates of 3 psi/min.

C. Packaging

West closure quantities can be packaged using the STERILIZABLEBAG (with a packing load oftwo (2) bags per carton). The following are guidelines for use:

Item Pieces/BagDental Cartridge Plunger 10,00013 mm Serum 10,00013 mm Lyo 5,00020 mm Serum 3,00020 mm Lyo 2,00028 mm IV 1,00028 mm IV Lyo 500

32 mm IV 50032 mm IV Lyo 500


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D. Opening

To reduce the generation of particles when opening the bag, West suggests the followingprocedure: Place the bag on a non-shedding surface. Cut through the HDPE side of the bag

with an extremely sharp knife blade (i.e., X-ACTO

). Renew the knife regularly (+/- every 500bags), depending on the type of knife material (diamond knives last longer). Avoid cutting theTyvek side if possible.

VI. Summary

This document is intended to provide general guidelines only. Ultimately, it is the customer'sresponsibility to evaluate and test the West item to determine its compatibility with a particular

product and that products end use, and to determine the tests and evaluations that are necessaryfor those purposes. West Technical Customer Support representatives are available to discuss andevaluate specific details of each customers application and process.

This technical bulletin dated November 7, 2008, supersedes any other previously released versionsof this bulletin.

2008 by West Pharmaceutical Services, Inc., Lionville, Pennsylvania, U.S.A.

All rights reserved. This material is protected by copyright. No part of it may be reproduced,stored in a retrieval system, or transmitted in any form or by any means, electronic,mechanical, photocopying or otherwise, without written permission of West PharmaceuticalServices, Inc.

TYVEK

is a DuPont registered trademark for its spunbonded olefin.X-ACTOis a registered trademark of Hunt Corporation.

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TSB 2000010 Technical Overview of the STERILIZABLEBAG