Technical Overview of the STERILIZABLEBAG

I. Background In pharmaceutical manufacturing, steam autoclave is the preferred sterilization technique for a wide variety of closures, packaging components and supplies including stoppers, seals, instruments and equipment. A method for packaging closures prior to sterilization and for maintaining sterility of closures after autoclave treatment is the STERILIZABLEBAG. The bag is considered environmentally friendly, heat sealable and a sterilizable protective package. West Pharmaceutical Services (West) developed the STERILIZABLEBAG to meet market needs in Europe for the replacement of medical paper bags and in the United States for the replacement of stainless steel containers. TYVEK , a DuPont material globally recognized as a standard of excellence for sterile packaging, is utilized for the STERILIZABLEBAG. TYVEK is specially engineered 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 density polyethylene (HDPE), and is heat sealed on three sides. The bags are available in a standard 400 mm X 500 mm size. TYVEK material is spunbonded olefin produced from very fine continuous filaments of high density polyethylene bonded by heat and pressure, and contains no anti-static compounds, fillers or additives. Both the TYVEK and HDPE comply with the United States Food and Drug Administrations food packaging requirements and comply with regulations of most European countries. Since both sides of the bag are HDPE, and as such have similar chemical properties, there is high resistance to most acids, bases and salts. However, prolonged contact with strong acids and bases may 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, in tests using a tumbling apparatus, TYVEK generates far fewer particles as compared with standard medical papers as reported by DuPont. B. Liquid Resistance TYVEK generally has approximately twice the resistance to liquid water penetration compared with standard medical papers. Even though resistant to liquids, TYVEK maintains high permeation rates for gases and water vapor. Additionally, permeation properties as tested by Gurley Hill Porosity (TAPPI T460 ISO 5636-5) are excellent and maintained even after steam sterilization up to 127 C.

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Technical Support Bulletin 2000/010

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Technical Overview of the STERILIZABLEBAG

C. Puncture Resistance TYVEK generally has between ten and twenty times the puncture resistance compared with various medical papers as reported by DuPont. This increased puncture resistance is an added feature in reducing the possibility of package penetration during rough handling and with contact of sharp objects such as metal caps and seals. IV. Attributes of the STERILIZABLEBAG A. Labeling The STERILIZABLEBAG will accept standard adhesive labels. Testing should be performed by the customer on a per application basis to ensure that each type of label used adheres during the sterilization and processing cycles. Also care should be taken in location placement of labels to prevent transfer of adhesive backing into the interior of the bag, which may contaminate 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 will change color after a typical autoclave cycle. C. Suggested Storage and Handling Recommended storage is in the original sealed shipping container and under typical pharmaceutical warehouse conditions. V. STERILIZABLEBAG Recommendations 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 of the 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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Technical Overview of the STERILIZABLEBAG

B. Steam Sterilization As TYVEK is high density polyethylene, the recommended sterilization processing temperature is 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 leaving space 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 TYVEK side up.) Autoclaving the bags will be different based on the size of the item, the number of items in the bag and the type and size of the autoclave and its capabilities. The following functions should be included: pre-vacuums, purges, sterilization not to exceed 124 C, post-vacuum and drying (if applicable). To reduce the possibility of damaging the bags during the sterilization cycle, a preconditioning cycle with the following parameters is recommended. Using a pressurization 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/evacuation rates of 3 psi/min.

C. Packaging West closure quantities can be packaged using the STERILIZABLEBAG (with a packing load of two (2) bags per carton). The following are guidelines for use: Item Dental Cartridge Plunger 13 mm Serum 13 mm Lyo 20 mm Serum 20 mm Lyo 28 mm IV 28 mm IV Lyo 32 mm IV 32 mm IV Lyo Pieces/Bag 10,000 10,000 5,000 3,000 2,000 1,000 500 500 500

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Technical Overview of the STERILIZABLEBAG

D. Opening To reduce the generation of particles when opening the bag, West suggests the following procedure: 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 500 bags), depending on the type of knife material (diamond knives last longer). Avoid cutting the Tyvek side if possible.

VI. Summary This document is intended to provide general guidelines only. Ultimately, it is the customer's responsibility 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 necessary for those purposes. West Technical Customer Support representatives are available to discuss and evaluate specific details of each customers application and process. This technical bulletin dated November 7, 2008, supersedes any other previously released versions of 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 Pharmaceutical Services, Inc. TYVEK is a DuPont registered trademark for its spunbonded olefin. X-ACTO is a registered trademark of Hunt Corporation.

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