Manufacturing
Inside the
clean zone
Sterile manufacturing in pharmaceuticals ensures products such as injectables and implants are produced in microorganism-free environments using stringent controls and sterilisation. In contrast, non-sterile manufacturing applies to products like tablets and syrups, focusing on meeting strict microbial limits without requiring sterility. Both processes are essential for ensuring product safety and regulatory compliance. Lorraine Mullaney explores the difference between sterile and non- sterile manufacturing according to the MHRA, speaking to experts along the way.
England’s independent body, the Healthcare Safety Investigation Branch (HSIB), launched an investigation in August 2021. The resulting report, ‘Decontamination of surgical instruments’, published in May 2022, identified several gaps in the UK healthcare system that could risk patient safety as a result of contaminated surgical devices. These ranged from a lack of national reporting and gaps in governance to “significant variance” in the training and competence of staff responsible for the decontamination of surgical instruments. The report also raised concerns about
A 10
fter a serious safety incident, in which surgery was performed on a patient with a contaminated surgical instrument, the NHS
how surgical instruments were designed, which it said did not give adequate consideration to the decontamination process required after use. Designing devices in a way that makes them difficult to clean increases the risk of patient contamination. In addition to improving instrument design, the report also recommended establishing national reporting mechanisms, enhancing governance and assurance processes, and standardising training and competency frameworks. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market and enforcing stringent Good Manufacturing Practice (GMP) to ensure products are safe for patients and meet quality
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
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