Client Background
A contract development and manufacturing organization in Penang, Malaysia operates Grade C/D cleanrooms with sterile-filling support areas. Before a scheduled GMP inspection, the team needed to requalify its filtration and personnel/material flow equipment.
The Challenges
- Existing supplier documentation did not provide batch test reports or serial-number traceability.
- H14 terminal filters with DOP test ports were required, while the available local option did not include the needed verification provisions.
- Personnel and material transfer points had been identified as contamination risks during gap assessment.
The WISHE Solution
- H14 HEPA terminal filters with DOP/PAO test ports and individual factory scan-test reports referencing EN 1822.
- SS304 personnel air showers and dynamic pass boxes with electronic interlocks.
- Horizontal laminar-flow clean benches for critical support operations.
- An English documentation pack including certificates of conformity, test reports, material certificates, and batch traceability.
Results
Validation note: The following performance indicators are from the supplied project draft and should be checked against project records before external use.
- The draft records that the filtration qualification file was accepted during the GMP inspection process.
- The supplied reference notes a shorter controlled material-transfer cycle after interlocked pass boxes were installed.
- The brief records scheduled filter changeouts completed without interrupting production batches.