Pharmaceutical and Medical Device Microbiology Instrument Services

Keep your microbiological testing systems effective and compliant

Preventive maintenance: enhance performance, extend lifetime and optimize your investment

Preventive maintenance and system verification ensures efficient operation of critical microbiological 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. We recommend checking and calibrating your microbiological testing 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

Repair coverage: peace of mind

All defective spare parts will be replaced during the scheduled maintenance or in case of a break down. There is no additional cost for spare parts during the repair coverage period (1 year); see technical appendix for list of parts covered.

Comprehensive documentation: full traceability and auditability

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. For air samplers we also provide a certificate of calibration. These documents ensure compliance with regulation and have a validity of 1 year.

Service plans: choose the coverage you need

We have the technical expertise and qualified personnel to service your equipment in our service center or at customer site, depending on the location. In case your equipment cannot be serviced in your lab, we coordinate the shipping logistics of your equipment to our service center.

 

 

About our different types of instrument services

Type of service plan Preventive maintenance Repair coverage
Preventive Maintenance including service kit Yes No
Repairs No All
Spare parts No Yes
Travel and/or shipment fee Yes Yes
Priority at service center Yes Yes
Performance report Yes Yes