- Validation of filtration for the filtering elements (directly in specialized Pall laboratories)
The validation of the filtration for the filtering elements is achieved directly in the specialized Pall laboratories. The package of validation includes all the types of tests:
- compatibility;
- extractible;
- the evaluation of the effects of the absorption of the components in the filtering environment;
- the viability of germs;
- the bacteriological retention study;
- the generation of the parameters for testing the integrity of the filtering environment after moistening with the product solution.
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- IQ, OQ for the equipment delivered
IQ, QQ - the protocols of validation are suggested by the suppliers of equipments, observing all the requirements of GMP rules. The customer has the possibility of consulting the protocols before beginning the validations of the acquired equipments.
- Assistance in PQ under direct supervision of the experts of the suppliers
PQ - may be achieved under the direct guidance of the specialists responsible for the performance of these types of tests, on the basis of the details provided on the applications which shall be developed with the help of the furnished equipments.
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- Calibration services for tester verification (integrity of sterilizing filtering medium) - PALL
The testers used for verifying the integrity of the filtering elements are very performing and extremely flexible
- Palltronic Flowstar FFS02
The tests of integrity may be easily performed even at distance, in the case of the verification of the integrity of the filtering vent cartridges, mounted on the tanks of preparation and storing.
- Palltronic Flowstar FFS04
All Pall testers allow the performance of the 3 types of tests of integrity used for testing the filtering hydrophilic and hydrophobic environments, respectively: Bubble Point, Forward Flow and Water Intrusion.
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- Integrity testing of sterilizing filtering medium - PALL
The services of calibration for Pall integrity testers are annually performed for all the testers sold to the customers in Romania, within a session organized at the headquarters of the company Process Engineering.
The training according to GPM - Pall Company offers a varied training program both for the operators and for the engineers and pharmacists, as regards the following aspects:
- the handling and sterilization of the filtering sterilizing elements in place and in autoclave;
- the handling of the filtering plates;
- the fundamental principles of filtration;
- the validation of the filtering sterilizing membranes according to PDA technical report 26;
- the performance of the integrity tests for the filtering hydrophilic environments;
- the performance of the integrity tests for the filtering hydrophobic environments;
- The advantages of the usage of the "Single-use" type systems
- Tangential Flow Filtration - membranes and cassettes
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