Equipment Validation Services
We use the best in quality industry-standard validation equipment to provide you with reliable and repeatable results on every temperature mapping validation project. Our inventory of mapping validation equipment allows flexibility in choosing the data-points and parameters to include in the temperature mapping validation study.
Qualification and Validation Services
RS Calibration Services engineers are experienced with using GAMP5 and ISPE approaches in executing automated and equipment validation projects.By deploying the streamlined process oriented methodology (POM) consistent with GAMP and ISPE procedures and templates,RS is able to simplify and control the cost of qualification and validation.We offer practical solutions based on ASTM E2500-07 and ISPE guidelines that provide quality and ensure a more cost-controlled, efficient project.Our solutions and process oriented methodology applies the concepts and principles introduced in the FDA’s document titled ‘Pharmaceutical cGMPs for the 21st Century-A Risk-Based Approach’, and in the ICH Q8, ICH Q9, and ICH Q10 documents.
RS Calibration provides temperature mapping, humidity mapping and validation services for temperature critical equipment. We perform testing over a range of -196 to 400°C and 0 to 95% RH.
We perform temperature mapping and validation on various healthcare, process validation, laboratory and storage equipment including:
- CO2 Incubators
- Shaking Incubators
- Stability Cabinets
- Humidity Chambers
- Various Ovens
- Freeze Dryers
- Various Ovens
- Spray Coaters
- Ultra Low Temperature Freezers
- Cold Stores
- Freezer Rooms
- Liquid Nitrogen Tanks
We use GE Kaye Validators Model 2000 and wireless data logger temperature mapping systems capable of logging a detailed analysis of your temperature critical environment performing work to either RS Calibration Services protocols or Customer’s own generated protocols.
RS Calibration Services has recently invested in wireless data loggers to drive efficiencies while providing precision and accuracy of measurements and reliability to support our customers validation requirements.
Our validation engineers work onsite with your team and work to specific project deadlines. A validation binder is reviewed by our Validation Engineer and QA staff. A final version is delivered to the customer at the conclusion of the project.
Our validation services include:
- Validation Engineer with over 10 years of experience in cGxP and cGMP environments
- RS Calibration generated protocols written to FDA standards
- Customer Provided Protocols
- Validation Package Includes:
- User Required Specifications
- IQ,OQ,PQ protocols for cGxP requirements
- Unit specific Operations Manual
- Critical pass/fail analysis
- Performance charts
- Pre and post qualification reports for temperature recording devices
- Certificates of calibration for all test equipment
Do you have any questions about temperature mapping or validation?
Please complete the information below and submit.