Equipment Validation
Qualification of Isolators
Isolators are tested according to EN12469 and/or GMP Annex-1 or according to customer’s requirements. The performance of the equipment is critical to the protection of the product and the operator. It is therefore vital that the equipment is qualified periodically. We have been working for several years with large pharmaceutical companies to carry out these qualifications. The services provided by CMI are only performed by trained service Engineers. All results are summarized in a detailed report, together with copies of the appropriate certificates of calibration for the validation equipment used. We can also provide 21 CFR part 11 compliant continuous monitoring solutions for isolators like.
– Pharmaceutical isolators
– Cytostatica units
Microbiologocal Safety Cabinets
CMI has been known for years as a trusted and independent partner for the validation of microbiological safety workbenches and laminar airflow systems. We are often challenged to validate new devices after delivery or relocation. These validations take place in accordance with the applicable standards. On request, customer-specific tests can be added to the validation protocol.
Standard tests we perform are:
Differential pressure measurement of the HEPA filter
Air velocity measurements just below the HEPA filter
HEPA Filter leak test according to ISO 14644-3 (filter integrity testing)
Determination of the dust particle concentration according to ISO 14644-1 or GMP annex-1
These tests can be extended to include tests such as:
Airflow visualization studies and recording of the airflow pattern
Microbiological sampling by active air sampling, contact plates (surface contamination) and settle plates
Determination of sound level and light intensity
Performing IQ OQ validations, whether or not in collaboration with your equipment supplier
In case the HEPA filter(s) need to be replaced our experienced validation engineers can also provide this service and re-qualify your HEPA filter(s) the same day to avoid costly downtime for your organization. Additionally, we can also perform the necessary decontamination of your microbiological safety workbenches by means of H2O2 disinfection (VHP) including monitoring report of the disinfection cycle.
Qualification of Weighing Enclosures
The weighing enclosures are tested according to ISO 14644-3 and according to customer’s requirement. Weighing Enclosures are designed for personnel protection while weighing powder substances. The filtration system ensures the highest level of protection for the operator. To prevents balance fluctuations the airflow in the work opening should be a smooth turbulence-free airflow without compromising containment. By performing a qualification we can give you the certainty that the enclosure is still working properly and if necessary the filter system can also be replaced. We also do these qualifications for suppliers of these devices.
All results will be summarized in a detailed report, together with copies of the appropriate Certificates of Calibration of the test equipment used.
Some examples of these devices:
Powder weighing enclosure
Bulk powder enclosure
Qualification of Fumehoods
A fume hood is often the primary device to control exposure from the laboratory workers when working with flammable and/or toxic chemicals. To capture vapours adequately , a fume hood should provide protection by an adequate face velocity over the entire working area. Therefore an annual qualification is recommended to validate your fumehood according to EN 14175.
We test the following parameters:
Inflow / Face velocity
Deviations from the average velocity
Airlow Visualization studies
These can be extended with optional tests such as:
Carbon Filter Replacement
Determination of sound levels
Determination of the light intensity
Performing IQ OQ protocol / validations, whether or not in collaboration with your supplier
Some examples of these devices:
– Benchtop filtration fume hoods
– Educational filtration fume hoods
– Floor mounted fume hoods
– Storage cabinets
– Laboratory extraction arms
HVAC Equipment Validation of:
Weighing Enclosures
Extraction workbenches
Isolators
Glove boxes
Fumehoods
Vertical and horizontal laminar flow workbenches
Microbiological safety workbenches EN12469 Class I, Class II (IIA and IIB) and Class III
Laminar flow housings over production lines or high tech setups
Execution and reporting
Reports are filled out according to GDocP (Good Documentation Practices) and verified by our own internal QA department before the official report is presented to the customer. The report includes all raw data in compliance with Annex 11 (21 CFR part11) , calibration certificates of the equipment used and conclusions / recommendations based on the results of the measurements.
