Aseptic services

Performance qualification

28 August 2026Performance qualification is the final step in the qualification process and ensures the pharmacy aseptic clean room suite functions correctly in routine use.

Operational qualification

28 August 2026Operational qualification provides evidence that the installed cleanroom equipment, facility, or control systems function correctly.

Installation qualification

28 August 2026Installation qualification provides evidence that the installed cleanroom equipment, facilities, or control systems have been installed correctly.

Design qualification

28 August 2026Design qualification is the first step in the process of qualification of pharmacy clean rooms.

Understanding clean room qualification

28 August 2026An overview of the qualification stages throughout a pharmacy clean room build project.

Writing the User Requirement Specification

28 August 2026The user requirement specification defines the aseptic service's requirements in terms of function, performance, operability and quality.

Writing a business case for a clean room build

28 August 2026The business case outlines the expected benefits and costs of the project and the reasons for the preferred option.

Assembling a clean room design and build team

28 August 2026Successful delivery of a design and build project requires a suitably skilled, resourced and coordinated team.

Planning a new build project

28 August 2026Planning a new clean room build project requires careful consideration to ensure all factors are understood and to ensure all requirements are known.

Designing and building pharmacy aseptic clean rooms

28 August 2026A systematic approach to planning, commissioning, building and validating pharmacy aseptic clean room suites ensures their fitness for purpose.