How To Mitigate Particulate Contamination In cGMP

Keeping drug products free from particulate contamination is essential for patient safety, product quality, and regulatory compliance under current Good Manufacturing Practices (cGMP). These contaminants, which can originate from the manufacturing process or external sources like hair and fibers , can compromise drug quality, reduce shelf life, and even trigger adverse immune responses in patients.

Manufacturers face several challenges, including detecting the source of particulates, keeping up with regulatory changes like USP <788> and EU GMP Annex 1, and preventing raw and packaging materials from shedding contaminants.

An often-overlooked strategy for mitigation is the proper selection of bottles. Bottles act as the primary containment barrier, protecting products from external contaminants. Choosing pre-rinsed, sterilized, and low/ultra-low particulate bottles is crucial, as they are manufactured to meet or exceed standards like USP <788>. This choice not only enhances product purity and patient safety but also improves operational efficiency by reducing cleaning steps.

Click below to learn more about the critical role of bottles in controlling particulate contamination and ensuring product integrity in cGMP environments.