Keep It Clean

R5 Pharmaceuticals has recently embarked on the construction of a new sterile facility to manufacture aseptic and terminally sterilised injectable products for Phase I and II clinical trials. In such a project, there are a number of issues involved that require careful assessment to ensure that it runs as smoothly as possible. Success is dependent on a process of rigid planning and careful implementation, minimising the difference between the expected outcomes and the final, delivered result.

EARLY-STAGE CONSIDERATIONS

As a result of increasingly stringent pharmaceutical regulations to ensure safety for patients using the products, the conceptual design of a new facility must be thoroughly analysed. The scope of the work (new chemical entities, biologicals or cytotoxics, for example), the scale of manufacture to be undertaken within the facility, and the type of build (refurbishment of an existing facility or green field site, for example) must be defined as primary objectives for the project as this will affect the design. Budgetary constraints should also be taken into consideration.

The use of the facility determines the exact requirements, therefore there are significant differences between those used for conventional sterilisation methods to those used for disposable technology. In a conventional facility, the manufacturing area is always quite large due to storage requirements of dedicated, stainless steel vessels, washing areas and the size of the sterilising autoclaves. If steam sterilisation of product contact parts is proposed, water for injection (WFI) must be available for final rinses after washing and for sterilisation.

If disposables are used for product contact parts, sterilisation is usually carried out through a process of irradiation. This makes a WFI plant less important; however, sourcing and validation of the sterile product contact parts requires integration into the project timelines.