A Contamination Control Strategy (CCS) identifies and evaluates contamination risks, explores mitigation options, and sets out plans for corrective and preventive actions. Its implementation addresses ...

Upperton has formally submitted its application to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for approval of its 7,000 sq. ft sterile manufacturing facility. This submission ...

Scale-up involves increasing pump sizes, reactor volumes, and flow rates—but the process control logic and system ...

High-performance coatings are a foundational component of cleanroom design, promoting sterility, cleaning efficiency, and ...

In this Pharma Matters Q&A, Amina Rahmoune of Nelson Labs evaluates and compares sterility testing in cleanrooms and isolators.

Regulatory pressure is another catalyst. The revised EU GMP Annex 1, which took effect in recent years, introduced stricter requirements around contamination control strategies, pushing drugmakers to ...

Explore how parenteral manufacturing solutions are evolving for specific drug formulations and meeting the demands of ...