Calitech : This is what our customer's want, what they need, and it is what we provide.


Standard
Equipment

The purpose of this Standard Operational Procedure is to provide a standard calibration procedure and standard calibration sheets for the calibration of all types of laboratory equipment.

Technical
Staff

“Calitech” calibration laboratory has strength of over twenty five experienced & extensively trained engineers to provide competent and reliable calibrations at laboratory or at customer's site.

Calibration

“Calitech” calibration laboratory has strength of experienced & extensively trained engineers to provide competent and reliable calibrations at laboratory or at customer's site.



HVAC Validation

Thermal Validation

Where environmental conditions, such as temperature, humidity, particle content and biological contamination are important aspects of pharmaceutical, biotechnical and or medical device production, validation and qualification of the HVAC system must be performed.

This validation must utilize a risk-based approach, which involves a high level of process understanding and focuses on potential problems, risks, and all suitable countermeasures. The validation must verify that in all areas where drugs or raw materials have air contact, the air cannot adversely affect the quality or efficacy of the product.

To fulfil regulatory requirements, a clean room HVAC system must maintain environmental condition within specified specifications. These conditions must be regularly monitored to ensure constant awareness of environmental conditions, such as temperature, humidity, pressure and particle levels. Digital outputs for alarms must also be monitored to ensure that an alarm will be raised if there is a change in any of the designated parameters.

All such environmentally controlled areas, zones and or rooms must be included in a preventative maintenance and calibration program that will monitor all trends and ensure continued use within the User Requirements specified specifications.

 
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