Clean Room Technology

Stringent requirements with regard to quality, purity and safety, which are laid down in comprehensive national and international standards and guidelines, are a prominent feature of the modern pharmaceutical industry. Actom clean room installations surpass the DOP, Particle Count, Establishment times, Air Flow pattern testing and specialised validation criteria required in this sophisticated and safety conscious industry to meet the requirements for all Grade A, B, C & D certifications. The implementation of Pressure Gradient Systems prevents contamination by foreign matter or active substances handled in the same production facility.

Actom – HVAC Systems (formerly Luwa South Africa) extensive technical expertise covers a large variety of tasks in the pharmaceutical research and manufacturing processes associated with Weighing Room, Sampling Booths, Dispensing, Pass Boxes, Component & Media Preparation, Granulation, Compression, Formulation, Gowning/Change Rooms, Airlocks and Liquids Filling Suites.

Actom - HVAC Systems (formerly Luwa South Africa) also designs, supplies and installs A/C systems for Stability Rooms, Conditioning Chambers, Laboratories, Primary & Secondary Packaging, Raw Materials Receiving, De-dusting, Quarantine, Ventilation and Extraction for Flammable Liquid Stores.

The application of fan units with H14 HEPA filters and RERA grid ceiling system guarantees mounting of the FFU’s in compliance with GMP standards and FDA standards or alternatively using CG screens ensures low-turbulence laminar flow, over the entire air outlet, at a given airspeed.

Actom - HVAC Systems (formerly Luwa South Africa) Engineering Department provides the following services.

• HVAC System Design
• Mechanical and Electrical as-built drawings for the layout of the HVAC equipment.
• Material of construction certificates for equipment supplied and installed.
• Warranty certification for equipment supplied and installed.
• Surface finish reports for equipment supplied and installed (if applicable).

Actom - HVAC Systems (formerly Luwa South Africa) Validation and Commissioning Department provides the following services.

• The submission of DQ, IQ and OQ documents based on each individual project specific URS.
• Commissioning of the system with the execution of all IQ and OQ activities.
• O&M manuals with all relevant information of HVAC equipment supplied and installed.