Practically in all areas of modern medical and pharmaceutical production, cleanliness and sterility are some of the most important parameters for ensuring a high and consistent product quality. Production in a controlled cleanroom environment is essential to permanently ensure these aspects. Tamper-proof and cost-effective monitoring of these environmental conditions is best done using an automated cleanroom monitoring system as part of the company's quality mangement system. In the GMP guidelines (Good Manufacturing Practice - Good Manufacturing Practice) or FDA and ISO guidelines, the requirements for the quality management system are explained. Depending on the product manufactured, different (product-related) environmental parameters should be monitored. Depending on the product requirements it starts with simple temperature monitoring going up to the complete monitoring of pressure, temperature / humidity, flow velocity and particle concentration, i.e.in safety cabinets and laminar flow systems.
Since the manufacturing and sales of products is ultimately at the discretion and risk of the manufacturer, in case of liability, the required proof that all environmental conditions were in compliance with the corresponding specifications all the way through the production process, has to be provided.
Anyway it's advantagous to verify the compliance with all relevant regulations prior to the construction start in order to uncover possible inadequacies at an early stage by the use of a risk analysis, avoiding cost expensive changes after completion. We are pleased to provide you with an example riskanalysis that encompasses the most important considerations.
Relevant EU / US standards
- EU GMP Guide
- 21 CFR part 11
- DIN EN ISO 13485 Medical devices - Quality management systems
- DIN EN ISO 13408 - Aseptic processing of products in health care
- EN ISO 14971 Risk Management - Medical Devices
- Directive 90/385 / EEC - Valid for active implantable medical devices
- Directive 98/79 EC - In vitro diagnostic medical devices
- Directive 93/42 / EEC valid for other medical devices class 1, 2a, 2b and 3
- DIN EN ISO 13488 Medical devices - Quality management systems
Advantages through the use of a monitoring system
- Gapless and tamperproof documention of environmental conditions
- Reduced staff expenses compared to manual recording
- Automated alerting protects you from physical injury and material damage caued by the violation of parameter limits
- Early recognition of deviations thanks to 2 stage alerting
- Reduction of operational costs through optimized operation (Reduction of air exchange numbers, temporarly deactivation of humidification during at rest state)