Final Packaging in a Sterilized Environment
Many manufacturing and final packaging processes necessitate a highly controlled and monitored environment, with the ability to inspect material particle levels for microbial contamination. As such, the Cleanroom is a sterile environment which enables such controlled conditions, managing and controlling possible contaminants down to the microscopic level.
In the medical industry, products are often considered high-risk commodities due to potential patient health hazards during usage. Therefore, they must be both safe to use and also meet the most stringent quality, cleanliness, and sterility standards. The essence of a clean room is to not just control and monitor the level of air cleanliness, but also to maintain multiple precise environmental factors, such as: temperature control, humidity control, permitted entry to qualified personnel only, and the introduction of working equipment that undergoes periodic calibration and control processes.
Producing products which meet the stringent quality and production standards of various industries requires final packaging processes to be carried out under the strict and controlled environmental conditions of a Cleanroom. Besides pharmaceuticals and medical device industries, this also includes industries such as:
- Aerospace
- Optical Technologies
- Electronic Semiconductor Manufacturing
- Biomedical Technologies
- Scientific Research and Development
ISO 7 Cleanroom General Information
- Cleanliness Level: ISO 7 Class 10,000
- Structure: Two-stage design with an ISO 8 gowning room
- Active Area: 12 square meters
- Air Exchange Rate: 38 complete air changes per hour
- Internal Work Hood: Equipped with a fume hood for vapor capture
- Validations: Passed GLP microbial validations
- Monitoring: Regular air sampling and cleanliness level assessments