APPLICATIONS
Pharmaceutical
A GMP cleanroom in Malaysia is graded A to D, and each grade has a different limit at rest and in operation.
Grade A and B suites sit at ISO 5 at rest. Grade C and D cover the surrounding areas. See the full ISO 14644 limits →
Holding the grade in operation
Satisfying both states is mostly carried by the pressure cascade and the airlock sequence. Dispensing and weighing areas need their own dust control, because there the product is the contamination. Surface selection follows from the cleaning agents, which is worth settling before the panels are ordered rather than after.
- Pharmaceutical manufacturing in Malaysia is regulated and inspected by the National Pharmaceutical Regulatory Agency.
- Malaysia is a member of the Pharmaceutical Inspection Co-operation Scheme, so facilities are assessed against PIC/S GMP.
- Grade definitions in PIC/S GMP are stated separately for the at-rest and in-operation states. Your design has to satisfy both.
- Halal certification for pharmaceuticals is assessed against MS 2424 where it applies to your product.
What we supply
- Grade C and D room systems
- Pressure cascade and airlock design
- Terminal filtration and FFUs
- Qualification documentation support
GMP facilities in Selangor and the Klang Valley
Most of Malaysia's pharmaceutical and registered supplement manufacturing sits in Selangor and the Klang Valley, in Shah Alam, Puchong, Rawang and Petaling Jaya. Those plants tend to be older and tighter on ceiling void than the drawings suggest, and the available void is usually what decides whether a reclassification is feasible at all. It is the first thing worth measuring.
Our office is in Kota Damansara, Petaling Jaya, which puts most Klang Valley sites within a short drive for a site assessment.
Send your floor plan and target class. Request a site assessment →