QATECH is highly skilled and experienced in providing Excellent services, High degree potential and excellent commitment for services
From the smallest bench top oven, to the largest sterilizer, (and everything in between), QATech can put a package in place which will not only meet your validation requirements, but exceed your expectations!!
If you already have a validation protocol in place, then we can execute it for you. However if necessary, we can help to draw up a protocol which suits your specific application.
- Traceability to national and international standards such as HTM 2010
- CFR21 Part 11 compliant software
- Robust quality system including ISO 9001:2008
Clarity of Reporting
• We use OEM software's .These software was designed specifically for sterilizer validation, so all the relevant information is available at the click of a mouse, and presented in a comprehensive but clear report.
• Customized solutions created and developed by experienced and highly qualified staff.
You can be assured that as an independent specialized service provider Qa Tech will continue to innovate our services to meet your current and future requirements.
Temperature Mapping of cold storage areas & Warehouses
There's increased emphasis by regulators on compliance with GMP requirements for controlled temperature storage requirements. QATech has the equipment and experienced professionals to help you achieve compliance in this area
Why do temperature mapping?
Clause 3.19 of the PIC/S GMP guide states:
"Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored."
How to cost effectively meet your compliance obligations
Temperature mapping can be a costly exercise. With multiple probe locations required it can be expensive to purchase and maintain the necessary equipment.
QATech can provide all the necessary equipment and calibration data for your temperature mapping exercise, so that you don't have to buy, maintain and know how to use it.
A temperature mapping exercise comprises four broad activities:
• Protocol development
• Temperature mapping
• Data analysis
QAtech can do all of these services, as well as an ongoing mapping service after the initial protocol development.
QATech's temperature monitoring equipment includes wireless capabilities. This makes mapping large warehouse and cold rooms much simpler. Mapping performance can be checked in real time, providing a real advantage over the standard multiple battery operated data logger approach. In-built reporting provides consistency and certainty to data outputs.
We execute validation of following equipments and facilities by keeping in mind about the critical requirements of various regulatory authorities and Latest GMP, GLP requirements in the industry.
• Temperature and Humidity Room Qualifications
• Temperature and Humidity Warehouse Qualifications
Temperature mapping experience includes :
• Portable Storage Units
• Clean in place (CIP)
• Steam in place (SIP)
Master Instruments List for Temperature Mapping
|Sr. No.||Instrument Name||Make/Model||Range||Accuracy||Qty|
|1||DATA LOGGER||EUROTHERM DEL INDIA LTD/6180V.||PT 100 (-200 to 850°C)||±0.01°C||2|
|2||DATA LOGGER||EUROTHERM DEL INDIA LTD./6180A-U48||PT 100 (-200 to 850°C)||±0.01°C||1|
|3||DATA LOGGER||YOKOGAWA INDIA LTD./MV1024-1-4-2-2-3F||PT 100 (-200 to 850°C)||±0.15% of rdg + 0.3°C||2|
|4||DATA LOGGER||YOKOGAWA INDIA LTD./MV2040-1-4-2-2-1F||PT 100 (-200 to 850°C)||±0.15% of rdg + 0.3°C||2|