Improving Sterility Assurance Within Lower-Grade Cleanrooms

By Christian Dunne: AseptiSafe Global Product Manager, ChargePoint

An increasing number of drugs, particularly those used in the treatment and prevention of the most serious diseases, are produced in sterile injectable dosage form. Any contamination of these raw drugs and formulations during manufacture could be catastrophic, particularly in vulnerable patients, where infections would pass the body’s defences and could be fast acting. This could also have major ramifications for the manufacturer in terms of their reputation, ability to supply, and, ultimately, safety of the patient.

While contamination issues can, in most cases, be picked up during validation and manufacturing, this will still mean a potential lost batch for the manufacturer and the loss of production time while the production line is stopped to allow for internal investigation, cleaning, decontamination, and re-validation. It is likely the manufacturer will also have to put new procedures and training in place.

Sterile drug production has historically relied on cleanrooms. These are designed to keep the entire working space at a specified level of cleanliness to reduce the risk of contamination. Strict gowning procedures and operator techniques also play a major part in contamination control. However, these approaches are challenging and costly to maintain. It also requires operators to wear bulky personal protective equipment (PPE), which can be uncomfortable and may make operating equipment more awkward. An overreliance on operator intervention has also proved to be one of the largest contributing factors for contamination. Because of this, the industry is moving toward using techniques to isolate the process from the operator and production environment while keeping smaller areas at Grade A (ISO 5) levels of control, working within larger spaces that can be maintained at a lower level, such as Grade C or Grade D cleanrooms.