The USP monograph for Sterile WFI states a requirement for 1L glass bottles. We wish to use 5L bags of SWFI for preparing a parenteral product. It is clear that WFI can be used for parenterals and SWFI is not required; however, the company prefers to use SWFI. Is there any reason why a 5L bag cannot be used for the production of parenterals when the SWFI meets all monograph requirements other than the container size? If the 5L bag can be used, where can I find the regulatory reference for this practice?
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Cynthia Green RAC
President
Northwest Regulatory Support
Maple Valley WA
United States
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