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As one of its first initiatives, the BPSA Technology Committee conducted an initial review of referenced quality test methods and specifications currently applied to common components of single-use systems: filter capsules, films and containers, tubing, and connectors and fittings. Recognition of consensus quality test methods, referenced to established industry standards and regulatory bodies, can help guide users when making their selections and can facilitate qualification, validation, and use of single-use products. Ultimately they can serve to elevate and maintain the level of excellence across the single-use industry.

Component Quality Test Matrices

For each single-use system subcomponent class — whether filter capsules, films and containers, tubing, and connectors and fittings — BPSA member manufacturers identified consensus quality tests. The matrices describe test methods in common language and list consensus reference documents along with testing frequency: at initial qualification, periodically, on sample lots, or (in the case of filter integrity testing) continually. The matrices also compare different test references used for specific test methods.

In many cases individual component manufacturers may conduct tests that go beyond these consensus methods or apply them with greater frequency. The methods here are intended to highlight common industry practices. You should also consider additional test data provided by component manufacturers or systems integrators when making your selections. In some cases, if your company requires conformance to standards such as in the international pharmacopoeia not listed in this document, you should contact the system or specific component supplier directly. As more single-use systems become available, BPSA is confident that adoption of this technology will gain even further momentum. The members hope that these quality test matrices will serve as a guide to maintain suitable component quality for operation of single-use systems in pharmaceutical GMP environments.

Online Content

Because the 10 pages of tables are more useful in an electronically searchable format, the downloadable file is available at www.bioprocessintl.com and at www.bpsalliance.org. There you can find the combined matrices for films, containers, connectors, fittings, tubing, and filters.

REFERENCE STANDARDS LISTED IN THE BPSA MATRICES

AAMI TIR27 Vdmax, Fluid Path (www.aami.org)

ANSI/AAMI BF7 (http://marketplace.aami.org)

ANSI/AAMI/ISO 11137 (http://marketplace.aami.org)

ASTM (www.astm.org): D395, D412, D543-06, D624, D746, D792, D882, D1003, D1004, D1434, D1599-99 (2005), D1709, D1790, D2240, D3418, D3985, D4169, D4728-9, D4991-94 (1999), E515, E1640, F88, F392-93 (2004), F838-05, F838-83, F1249, F1927, F1980

DIN EN 554 (http://webstore.ansi.org)

DIN ISO 2872 (www.iso.org)

EN 12266-1 and EN 30993-1, −5, −12 (www.cenorm.be/catweb/cwen.htm)

European Pharmacopoeia (http://online.pheur.org/entry.htm): EP 2.6.1, 2.6.14, 2.9.19, 3.1.5, 3.1.9, 3.2.2.1, 3.2.9

ISO (www.iso.org): ISO 527-3, 3968, 7241-2, 7765-2, 8570, 10993, 11134, 11137, 11357-2, 11359-2, 15105-1, 15105-2, 15106-1, 15106-2, 15106-3

ISTA, ISTA 2A (www.ista.org)

21 CFR 177 (www.gpoaccess.gov/fr/index.html): 177.1350, −.1520, −.1550, −.2400, −.2510, −.2600

United States Pharmacopeia (www.uspnf.com/uspnf/login): <71>, <85>, <87>, <88>, <381>, <643>, <645>, <661>, <788>, <791 >