ASEPTIC offers a full range of services, calibration tools, validation systems HVAC, LAF, hoods and cleanroom in compliance with the regulations.
ASEPTIC helps you to verify the integrity of contamination environments and temperature controlled, as well as the integrity of the equipment at their service. We provide documents, protocols and procedures necessary to meet Validation Master Plan (VMP)’ requisites. In this way we allow our customers to focus n their core activities of their environments.
Calibration and qualification services IQ,OQ and PQ allow to respect the conformity asked to the standards FDA, GMP/GPL, to requirements of the European pharmacopoeia and to the ISO standards.
The qualification procedures allow to state if the the equipment complies with the specification required.
ASEPTIC uses cutting-edge equipment, to ensure the accuracy and the reproducibility of the results during every phase of the project.
Our qualification protocols are based on producer’s suggestions or set on costumer’s level of conformity. This means that we supply customized protocols and producer’s standard protocols.
For equipments and tools already daily used we also supply a service of planed qualification. For this service we exclusively perform the qualification of performance and provide a status report which guarantees the equipment to comply with the respective laws.
The property of all the measurement instruments used , required for the validation and upgrading of the installations and the equipments, makes our services, unique and fast to costumers’ demand, allowing us to break down the intervention timing also during the periods of “stationary installations”.
Calibration, validation and qualification services are available for the following instrumentation:
- Biological safety cabinets and fume hoods
- HVAC systems and service tools
- Temperature, humidity and pression probes