Containment and pharmaceutical HVAC validation training

Highly successful first session of the ALPA Academy

Earlier this year, ALPA (Air & Lab Products Africa) co-hosted an in-depth training session together with Air Techniques International. Presented by Tim Triggs, EMEA Regional Director – Air Techniques International, who flew to South Africa specifically to present the courses on containment and pharmaceutical HVAC validation training, the four courses focussed on:

• Airflow measurement (in cleanrooms or controlled environments)

• Cleanroom classification (sampling airborne particles, numbers and sizes)

• HEPA filter integrity testing

• Microbiological Safety Cabinets and their certification in accordance with EN12469.

At the end of each course, an exam on the theoretical training was undertaken. The training took place from 20 to 24 January at Edgecombe House in Blue Hills, Midrand and attendees included consulting engineers, certifiers and quality assurance managers from the clean room and filtration industries.

Airflow measurement is critical to creating and maintaining a cleanroom or controlled environment and is a paramount requirement in applications for such industries as pharmaceutical, healthcare, nuclear, semiconductor, electronics, aerospace, automotive and laboratory sciences. Delegates were equipped with expanded knowledge on cleanroom and equipment designs, airflow principals, units of measurement, types of instruments, and the testing required.

Cleanroom classification is another important facet of our industry. There is a requirement in all cleanrooms and controlled environments to sample the airborne particle numbers and sizes for determining classification to ISO14644-1. Other regulated industries such as pharmaceutical and life sciences require testing for GMP classification, and monitoring for control, following the same procedures. Particle counting is more complex due to changes in the Standards and the technology used in Particle Counters. The course covered the types of cleanroom and clean air devices, the instrumentation to use and the functions, and how to test for classification.

HEPA filter integrity testing also formed part of the four-day training session. There is a requirement in all clean air and containment industries to test the HEPA filter systems that protect people, product and environment. ISO14644-3 describes the installed filter leakage test, commonly referred to as the DOP (Dispersed Oil Particle) test. Being the preferred method in all industries except microelectronics, this test is global and, whilst it appears simple, it can, in fact, be quite complex. The course covered testing installed HEPA filters, the most current equipment and the latest best practices.

Microbiological Safety Cabinets and certification in accordance with EN12469 – MBSCs are extensively used in containment applications throughout industries such as pharmaceutical, healthcare, nuclear, and laboratory sciences. Legislative requirements together with the European Biotechnology Standards and British Standards for safety cabinets make it vital that all those responsible for efficient and safe working of containment systems are familiar with both the theory and practice of their operation, performance and testing. S

hould any Analytical Reporter readers be interested in similar training, please give ALPA a call or email sales@alpa.bz.

The team presenting the training: Gregers Chalker, Preston Ngoyi, Lungile Mpofana, Thiloshini Pillay, Tim Triggs, Francois Swart

ALPA (AIR & LAB PRODUCTS AFRICA)

Tel: (064) 870 4046 sales2@alpa.co.za www.airlabproducts.co.za