Properties of Materials Used in Single-Use Flexible Containers: Requirements and Analysis - - BioPharm International

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Properties of Materials Used in Single-Use Flexible Containers: Requirements and Analysis


BioPharm International


Analysis: The film must be a barrier to oxygen at 8 C (since the solution is oxidizable); it must be sterilized before use (because it will be used in aseptic filling); and it must be resistant to acidic solutions (pH 5). The system needs to be able to contain large volumes (200 L), needs to have a non-invasive mixing system (since the solution must be mixed, and will be filled under aseptic conditions) and needs to resist a slightly acidic solution during storage for two to four weeks.

Proposed solution: A gamma-sterilized product composed of a 200-L bag made of a multilayer gas barrier film with a PE contact layer and a closed loop mixing system associated with a containment system.

Example 2:

Input data: Need to store a monoclonal antibody at –40 C for two months. The product is sensitive to bulk-scale freeze-concentration, and long-distance transportation is required.

Analysis: The container needs to withstand low temperatures. The system needs to offer protection to the frozen product during freezing, thawing, and transport. The contact layer of the product needs to have low protein adsorption properties to maintain yield. The freezing and thawing processes must be controlled to maximize the heat transfer and thus minimize freeze-concentration.

Proposed solution: A complete system with a controlled freeze–thaw unit able to process flexible containers made of a multilayer EVA-based material. Each individual disposable unit is assembled into a rigid frame protecting the product at every process step.

Conclusions

Single-use products have been on the market for quite a number of years and have become familiar items for most of the manufacturers in this field. This familiarity has the significant drawback that the technologies behind the single-use systems are taken for granted.

The choice of a solution for storage in single-use containers clearly depends on the application and the inherent risks associated with the application. Beyond the minimum requirements (biocompatibility, basic container–content fit, appropriate mechanical properties, etc.), a number of specific tests can facilitate the decision-making process to select the right single-use system. The two theoretical examples described in this article illustrate how the needs of an application will lead to very specific single-use solutions. A "one fits all" single-use system cannot respond to all the requirements that are specific to a particular step of a biopharmaceutical process, much less to all the steps of this process.

Magali Barbaroux is an R&D development leader, and Andrew Sette is the vice president of quality and regulatory affairs, both at Stedim Biosystems, Z.I. des Paluds–BP 1051, 13781 Aubagne Cedex, France, tel. +33 4 4284 5600, fax +33 4 4284 5619,

References

1. Paust T. Technology integration through disposable—from components to systems. ISPE Nordic conference on disposables in biopharma, 2006 May 30, Stockholm, Sweden.

2. Sinclair, A, Monge, M. Biomanufacturing for the 21st century—Designing a concept facility based on single-use systems, Pts 1 and 2, Bio Process Int. Supp, 2004 Oct, 26–31 and 2005 Oct, 51–55.

3. Smith-McCollum, B, Rosin, L, J, The Bioprocess System Alliance, BioProcess International, 2006 June; 4(6): S6–S8. See also http://www.bpsalliance.org/

4. Chapter <87>, Biological Reactivity, in vitro. United States Pharmacopeia 29–National Formulary 24, US Pharmacopeial Convention, Rockville, MD, 2005.

5. USP Chapter <88>,Biological Reactivity, in vivo.

6. USP Chapter <661>, Plastic Containers.

7. ISO 10993, Biological evaluation of medical devices. International Organization for Standardization, Geneva, Switzerland, 2003.


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