Cleanroom technology is used in the manufacturing of sterile and ultra-clean products and devices. This technology is based on the use of High Efficiency Particulate Air (HEPA) filters as well as engineering and procedural controls to provide a contamination-free environment in a determined area.

Omark Lifesciences adheres strictly to all GMP requirements and is ISO 9001 registered.

OMARK ASEPTICALLY-ASSEMBLED DISHES

1.From a quality point of view, aseptically assembled dishes are indistinguishable from terminally sterilized Petri dishes.

2. However, aseptically manufactured dishes have the added advantage of being free from chemical residuals produced by some sterilization processes that may inhibit the growth of fastidious microorganisms. Equally important, unlike those produced without the advantage of the HEPA filter, the dishes are now particulate-free.

OMARK LIFESCIENCES CLEANROOMS

Omark Lifesciences cleanroom facilities are soft-walled rooms. Each room is equipped with state-of-the-art (HEPA) filters. Process and product conformance are assured by controls and procedures outlined in our extensive Environmental Monitoring Program. More importantly is the air cleanliness, temperature and relative humidity control and rigorous clean floors.

Omark Clean room facility equipped with

HEPA Filters
Air Filtration
Fan Filter Units
Cleanroom Ceiling System
Temperature Control
Access Control
Inter Lock Door Systems
Air Showers

Unidirectional Airflow
Desiccator Cabinets
Horizontal Flow Wall Modules
Horizontal Laminar Flow Clean Benches
Laminar flow cabinets
Laminar Flow Canopy
All these aspects are described in well-documented protocols and incorporate various tests performed to recognized standards (US Pharmacopoeia, ISO 14644).

Product sterility testing is regularly performed by an independent microbiological laboratory. Sterility Certificates are issued for each lot manufactured and are retained in our master file. The certificates are forwarded to our valued customers upon request.