Keep Your Testing Systems Effective and Compliant
Ensure Optimum Performance
Preventive maintenance and system verification ensures efficient operation of critical testing equipment. Every system should be serviced regularly to ensure its performance remains compliant with the specifications, as per GLP 21 CFR 58.63 (FDA) and EU GMP vol.4, 3.41. Merck Millipore recommends checking and calibrating the systems on an annual basis. We can guarantee that your system meets our manufacturing specifications after preventive maintenance and service. Our maintenance team is also familiar with GMP/GLP procedures.
- cGMP require ALL equipment to be properly maintained
- 21 CFR §211.67: Equipment cleaning and maintenance “(b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product.”
- EU GMP Vol.4, 3.41: Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods
- Adequate records of such tests should be maintained
Comprehensive Service Plans
Upon completion of the service, we will provide you with a report defining the service performed on your equipment as well as our recommendations. In addition, this report guarantees that the equipment meets system specifications. These documents ensure compliance with regulation.
Annual Preventative Maintenance
Annual preventative maintenance will reduce the risk of breakdown by ensuring the equipment works within the system specifications.
All detective spare parts will be replaced during the scheduled maintenance or in case of a break down (Extended, Extended Plus and Total only). There is no additional cost for spare parts during the service plan period (see technical appendix for list of parts covered).
Peace of Mind
The service plan is as effective as a warranty. In case of repair, you will not pay for spare parts (Extended, Extended Plus and Total only). All service plans include:
- Visual and functional checks
- Calibration when relevant
- Priority repair (Extended, Extended Plus
and Total only)
- Spare parts for preventive exchanges
- Spare parts for repairs (Extended, Extended Plus and Total only)
- Performance report and Certification of Calibration (when relevant)
- Travel fee and/or return shipping cost