Mini-bulk containers used for storage of biologics after final filtration could cause rejection of the product. Many popular ready-to-use containers were developed years ago for R&D applications and at a time when container particulate burden was not an issue. Such containers are not fit for use with drug substance, because they often carry particulate burdens that exceed the limits of USP <788> Particulate Matter In Injections. With the coming implementation of USP<787> Subvisible Particulate Matter in Therapeutic Protein Injections, using containers not certified to USP <788> standards will only lead to future problems for vaccine and biopharma manufactures.
Example: Testing of a widely used range of bottles and carboys has shown particulate burden per ml of product that exceeds current USP standards at 10µ and 25µ(data not shown) and 50 µ (graph) in amounts that will contaminate product sufficiently to cause rejection.
After the implementation of USP <787> expect regulators to look more closely at manufacturing processes to ensure that particulate contamination is controlled and that the finished product is fully defined in terms of the expected particulate burden in product submission documents. Learn more at the Biofluid Focus blog