Validation Process
At KHTP Sterilisation Services (KSS), we uphold the highest standards of validation to ensure every sterilisation cycle delivers consistent, safe, and effective results. Our validation procedures are conducted in accordance with international regulatory requirements and best industry practices.
Biological Indicators (BIs):
We utilise biological indicators containing highly resistant spores (such as Geobacillus stearothermophilus) to verify the lethality of the sterilisation process. These indicators are strategically placed in the most challenging areas within the load to confirm complete sterilisation effectiveness.
Process Challenge Devices (PCDs):
Our process challenge devices are designed to replicate the most difficult-to-sterilise conditions of an actual load. Equipped with thermocouples or biological indicators, they help us assess and validate the overall efficiency and uniformity of the sterilisation process.
Validation Runs:
We conduct multiple validation cycles using either actual products or simulated test loads. Each run is carefully monitored, with key process parameters recorded and analysed to ensure repeatability and compliance with established specifications.
Microbiological Testing:
Post-validation, microbiological testing is performed to confirm the required level of microbial reduction. This includes testing for both aerobic and anaerobic organisms, ensuring each product meets the highest safety and sterility assurance levels.
Routine Cycle Process Flow
Our routine EO sterilisation services are designed for consistency, efficiency, and safety. With controlled processes and continuous monitoring, we deliver reliable results for medical devices and healthcare products.
Receiving and Inspection
Upon arrival, all incoming batch undergo a stringent receiving and inspection process. Each batch is verified against approved specifications, including product integrity, packaging condition, labeling accuracy, and compliance with sterilisation readiness requirements. Any deviations, damages, or non-conformities are documented and addressed before the products proceed to pre-processing. This step ensures that only conforming materials enter the EO sterilisation workflow, reducing risks during routine processing.
Strict Control of Critical Process Parameters
Throughout the EO sterilization cycle, strict control and continuous monitoring of all validated critical parameters are maintained to ensure microbial inactivation and process consistency. These parameters include:
- EO Concentration: Precise regulation of ethylene oxide concentration within the chamber to achieve the validated lethality level (SAL 10⁻⁶).
- Humidity: Controlled relative humidity to promote microbial hydration, ensuring effective EO penetration into packaging and device surfaces.
- Temperature: Stable chamber temperature to support EO vapor activity and maintain uniform thermal conditions across the load.
- Exposure Time: Accurately timed EO exposure to ensure sufficient contact duration for complete sterilisation efficacy.
- Aeration Duration: Defined aeration times to ensure desorption of EO residues and compliance with permissible residual limits.
All parameters are recorded through an integrated monitoring system, ensuring traceability and adherence to ISO 11135 requirements.
Quality Checks and Final Release
Before products are released, a comprehensive series of quality checks is performed to verify the safety and effectiveness of the sterilisation process. These include:
- Biological Indicator (BI) results to confirm microbial lethality.
Chemical Indicator (CI) inspection to verify exposure adequacy. - Residual analysis to ensure compliance with EO, ECH, and EG permissible limits.
- Cycle data review to confirm all parameters met validated specifications.
- Packaging integrity checks to ensure sterility maintenance through distribution.
Upon successful verification, the sterilised products are approved for release, ensuring they meet all regulatory, safety, and quality standards.
Lab Testing
ETO Residual Gas:
ETO residual gas testing is performed to ensure that any remaining ethylene oxide on or within sterilized medical devices is within the acceptable limits defined by ISO standards. Residual EO, along with by-products such as ethylene chlorohydrin (ECH) and ethylene glycol (EG), is measured using gas chromatography or other validated analytical methods. The results are then compared against established acceptance criteria to confirm that the products are safe for patient use.
Routine Monitoring and Environmental Testing:
Routine monitoring and environmental testing are conducted to maintain strict control over the sterilization environment. Parameters such as temperature, humidity, and EO concentration are regularly measured within the sterilization chamber, aeration areas, and surrounding facility spaces using calibrated monitoring systems. The collected data is reviewed to ensure that all conditions remain within validated and regulatory limits, guaranteeing consistent sterilization performance and a safe working environment.
Storage
Sterilized devices are stored in a controlled environment where temperature and humidity are carefully maintained to protect product integrity and prevent contamination. These controlled conditions ensure that all products remain stable and safe throughout the storage period.
Each device is assigned a defined shelf life based on material stability and the potential risk of microbial re-contamination over time. For routine sterilization cycles, a standard turn-around time (TAT) of 7 days is applied, ensuring efficient processing while maintaining compliance with quality and safety requirements.
A robust inventory management system is used to track all sterilized devices, including lot numbers, expiration dates, and storage locations. This ensures full traceability, accurate stock control, and proper rotation of products throughout the storage and distribution process.
