Steam and Dry Heat Sterilization Qualification and Validation (ISO/IEC 17020:2012 Accredited Service)

• Steam Sterilizers Validation/ Qualification : As per PDA Technical Report 1, EN 285, ISO17665-1, HTM 2010 PART-3.

• Depyrogenation Tunnels Sterilizers Validation/ Qualification : As per PDA Technical Report 3, HTM 2010 PART-3.

• Dry Heat Sterilizers Validation/Qualification : As per PDA Technical Report 3, HTM 2010 PART-3.

• Warehouse Thermal Mapping : As per WHO Technical Report Series, No.961.

• Ellab Supported Service Provider.

• Automatic Data Handling and Calculation Validation Equipment.

• Automatic Calibration and Error Compensation.

• FDA 21 CFR 211, EU GMP for Data Integrity Complied Software.

• Real Time Draft Report Delivery

IETQAN offers through its exclusive alliance with Multilab-Egypt a wide range of medical devices assessments using chemical characterization, in vivo and in vitro test services to meet international requirements of ISO 10993 series.

Primary test categories used to determine biological effect include:

• Hemocompatibility testing ISO 10993-4
• Cytotoxicity testing ISO 10993-5
• Intracutaneous irritation testing ISO 10993-10
• Sensitization testing ISO 10993-10
• Systemic toxicity testing ISO 10993-11

The service offered under accredited laboratory practice fullfiling the requirements of ISO 17025:2017.

Any medical device that is sterilized by ethylene oxide (EO) and comes in contact with a patient must undergo residual testing to analyze the EO residual levels. The residues can be harmful to the end user or patient, so it is important that all devices meet the limits set forth in the ISO 10993-7 standard. The limits will vary depending upon the intended use of the device. The study should be reviewed periodically, typically with the sterilization process validation, i.e. annually. . (FOR TEST PROTOCOL DETAILS CONTACT US).

ETO sterilization validation (ISO/IEC 17020:2012 Accredited Service)

is the documented procedure for obtaining, recording and interpreting the results required to establish that the sterilization process will consistently yield a product complying with predetermined specifications (ISO 11135:2014). Validation of the ETO sterilization process yields a documented procedure of consistently confirming the inactivation of all living microorganisms, confirmation that the product or device is sterile, and confirmation that the process is repeatable. The process validation is a key factor in any regulator with standard compliance technique. IETQAN can concurrently validate more than one sterilizer at a time. Reports are traceable and verifiable through IETQAN web site. This way you will be able to share the report with regulatory agencies and clients with high credibility level. (FOR VALIDATION PROTOCOL DETAILS CONTACT US)

Clean room validations (ISO/IEC 17020:2012 Accredited Service)

according to (ISO14644-1:2015) the documented procedure for obtaining, recording and interpreting the results required to establish compliance to ISO 14644 requirement. Validation is done according to a predetermined validation protocol. Periodic validations in accordance with a maintenance and validation program tailored to the individual clean room class. In practice, this usually leads to a validation interval of 12 months of clean rooms with ISO class 6 or higher. For clean rooms with ISO class 5 or lower, the validation interval is usually 6 months. Reports are traceable and verifiable through IETQAN web site. This way you will be able to share the report with regulatory agencies and clients with high credibility level. (FOR VALIDATION PROTOCOL DETAILS CONTACT US).

Packaging Validation (ISO/IEC 17025:2017 Accredited Service)

ISO 11607 is the principal guidance document for validating terminally sterilized medical device packaging systems. Packaging must comply with ISO 11607 in order to satisfy European regulations and obtain a CE Mark.  ISO 11607 is also an FDA Recognized Consensus Standard.  Fulfilling the requirements within ISO 11607 ensures that a medical device packaging system allows sterilization, provides physical protection and maintains sterility up to the point of use. Test reports are traceable and verifiable through IETQAN web site. This way you will be able to share the report with regulatory agencies and clients with high credibility level. (FOR VALIDATION PROTOCOL DETAILS CONTACT US)

Packaging Accelerated Aging Studies (ISO/IEC 17025:2017 Accredited Service)

Accelerated Aging - oftentimes referred to as Accelerated Shelf-Life Testing - is commonly used in the medical device industry to accelerate the effects of time on a Sterile Barrier System to establish Shelf Life parameters. The process is based on the relationship of temperature and reaction rate where an increase in temperature increases the reaction rate. Following validation ISO 11607 guidelines and ASTM F1980, accelerated aging data can be generated. Accelerated Aging data is acceptable by regulatory bodies as evidence to generate data quickly, but this data is only accepted until those tests can be correlated to "Real Time" samples. (FOR PROTOCOL DETAILS CONTACT US)