AUTOCLAVE VALIDATION
Autoclave Validation Services At FIRST Company.
We perform Autoclave Validation for Porous and Fluids load Autoclaves.
Our engineers perform Cycle Development, and Validation Services.
We use TQSOFT With Fluke Validation Equipment.
we perform Autoclave Validation to International Standards for the pharmaceutical, biotechnology and healthcare sectors.
Our experience and expertise will give you a clear, compliant and transparent autoclave validation package.
We can qualify your autoclave to EN285:2015, EN17665, PDA Technical Report 01 and PDA Technical Report 48 to meet MHRA, HPRA and FDA expectations.
We specialise in Autoclave Validation, regularly working with the following manufacturers: Fedegari, Getinge, Steris, Belimed, and more.
- Porous, Fluids and Waste Autoclave
- Qualification Installation/Operation Qualification (IQ, OQ)
- Autoclave Load Patterns and Load Presentation
- Performance Qualification (PQ)
- Re-Qualification (RQ)
- Steam Quality Testing
Autoclave Thermal Validation
DEPYROGENATION VALIDATION FOR TUNNEL / OVEN
Depyrogenation Validation Services At FIRST Company.
We perform Depyrogenation Tunnel / Oven Validation.
Our engineers perform Temperature Mapping, and Validation Services.
We use TQSOFT With Fluke Validation Equipment.
we perform Depyrogenation Validation to International Standards
Our experience and expertise will give you a clear, compliant and transparent validation package.
- Heat Distribution and Penetration Study
- Cold and Hot Points Detecting
- Depyrogenation Period Calculation ( Min , Max , Sterilization Time)
- Qualification Installation/Operation Qualification (IQ, OQ)
- Performance Qualification (PQ)
- Re-Qualification (RQ)
Depyrogenation Tunnel Validation
ETHYLENE OXIDE ETO STERILIZER VALIDATION
ETO Sterilizer Validation At EESS Company.
We provides ETO Sterilizer Validation services in accordance to ISO 11135
The main objective of validation is to ensure that the sterilization process has been consistent in achieving sterility and did not cause undesirable impact on the device or packaging. The tests conducted on ETO sterilized medical devices includes:
- Sterilization Cycle Development
- Physical Performance Analysis
- Temperature and Relative Humidity monitoring
- Pressure monitoring
- Empty Chamber Studies
- Loaded Chamber Studies
- Validation Maintenance / Revalidation
Our team ensures and prepares validation protocols which specify the procedures and tests to be conducted. Typical validation processes consist of the following:
- Leak Teat
- Commissioning Cycle
- Fractional, Half and Full Cycles
- Cycle Mapping and Load Pattern
EO Sterilizers Validation
Temperature and Humidity Mapping
A temperature mapping study is an exercise to qualify temperature and humidity mapping of storage environments used for temperature sensitive
products.
This can include but is not limited to Warehouses (Controlled, uncontrolled, Dedicated or Multi Market), Cold stores/Fridges, Freezers, Containers, Vehicles, Stability Chambers, Incubators)
The temperature mapping report will document any
recorded Hot & Cold spots as well as recommendations for continuous monitoring positions where required.
TEMPERATURE AND HUMIDITY MAPPING
TEMPERATURE MAPPING FOR WAREHOUSES
- Empty & With load (product)
- Summer & Winter
- External ambient temperature (outside of facility)
- Date stamp of any notable
- temperature and humidity mapping during normal operations
- Impact tests (e.g. HVAC power down, Door open tests)
- MKT (Mean Kinetic Temperature)
TEMPERATURE MAPPING FOR COLD STORES, VEHICLES, CONTAINERS, CABINETS (FRIDGES, FREEZERS, STABILITY CHAMBERS):
- Empty & With load (product)
- External ambient temperature (outside of
cabinet/cold store/vehicle)
- Date stamp of any notable
- Impact tests
- Mapped during normal operations
Contact us: info@first-env.com
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