Cleanrooms that manufacture pharmaceutical products must follow strict aseptic manufacturing practices and guidelines. Kenelec Scientific are pleased to announce that they can now ensure that particle counters meet the requirements for compliance to ISO 14644-1 and ISO 14644-2 as their accredited Particle Measurement Laboratory now calibrates and certifies Aerosol Particle Counters.
The cGMP and EU GMP guidelines define limits for airborne particle counts based upon specific cleanroom classification (e.g. Grade A, Grade B, Grade C, Grade D). However, the guidelines do not provide:
- Methods to determine the particle counts within a clean space
- Instrument to measure particle counts within a clean space;and
- Calibration methods for particle counters to assure data accuracy.
Therefore, the EU GMP suggests pharmaceutical manufacturers follow ISO 14644-1 for determining particle counts and classifying clean spaces and ISO 14644-2 for instrumentation guidelines that demonstrate continued compliance. The new ISO 21501-1:2009 provides calibration methods to assure data accuracy and meet the requirements for ISO 14644-1.
For further information regarding the Calibration Services available from Kenelec Scientific please visit the website.