In May this year, US Pharmacopeia (USP) chapter 665 will come into effect, and mandatory testing for extractables and leachables (E&L) studies of plastic single-use systems are now required. Moreover, the BioPhorum Operations Group (BPOG) industry collaboration has published protocols that provide comprehensive data, which allows manufacturers to compare materials from multiple suppliers. SAXOCON can help your company ensure that your materials are compliant and that your suppliers provide high-quality, traceable products.
Pharmaceutical manufacturers have increased their use of single-use systems (SUS) to lower costs and increase efficiency. SUS substitutes polymers for glass and stainless steel. Polymers have many advantages but require extra vigilance when selecting materials and vendors.
As polymers present a greater leachables risk, they are subject to greater regulatory scrutiny. These regulations specify the limits that leachables must be under but do not provide guidance about testing.
The USP 665 standard covers the characterisation and qualification of single-use technology (SUT) using plastic components and systems for manufacturing pharmaceutical drug products and biopharmaceutical drug substances and products. One of the central concepts of testing per USP 665 involves exposing materials to temperature extremes and solvents.
USP 1665 provides guidance on applying USP Chapter 665, including suggested risk assessment approaches and how to implement them.
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