Validation Services
Sterile products are also vital in the production process to remove residues and impurities that may remain on the product and to reduce the amount of biological load that may remain on the product.
We provide training on how to define the cleaning process that is appropriate for your product, determine the parameters and verify the washing process. In this direction, we carry out cleaning procedures and cleaning instructions related to your products and define how to follow the cleaning process.
Sterilization Validation
Sterilization of medical devices is vital in the medical sector. Sterilization is a necessary process for most medical devices, which are often required by regulatory authorities. It is a process to purify the product from bacteria and other microorganisms that cannot be removed by regular cleaning processes. Therefore, sterilization requirements are addressed separately in ISO 13485: 2016.
Sterilization offers three safe conditions for surgery
Safe conditions for surgery indicate a situation where the patient, medical devices and the environment indicate minimal risk of surgical-related diseases and other medical problems. Safe medical conditions during surgery are extremely important because these conditions ensure the patient's own safety during surgery. Medical sterilization is therefore of critical importance because it provides three different medical safe conditions in surgery:
Sterilization stops the growth of bacteria in the devices and ultimately prevents the transfer of bacteria to the patient.
Sterilization stops the spread of fatal diseases such as HIV from devices to patients.
Sterilization prevents infections that may require additional surgery.
Sterilization requirements and how to comply
Sterilization requirements are spread throughout the entire ISO 13485: 2016 standard.
The Sterile Medical Device (Article 3.20) of ISO 13485: 2016 states that the sterility requirements of each medical device may be subject to applicable legal requirements.
Pollution control (see 6.4.2) is intended to prevent contamination after the devices have been sterilized. Controls may include dust collectors and ventilation systems and are monitored by air quality tests at a certain frequency in the assembly and packaging areas after sterilization.
Specific requirements for sterile medical devices (see 7.5.5) specify two direct requirements:
Records of sterilization process parameters of each batch - Sterilization process parameters must be recorded for each batch. Process parameters, pressure in the sterilization unit, temperature in the sterilization unit, gas flow rate in the unit, operator name and humidity etc. Includes environmental conditions. All process parameters that may affect product quality must be recorded for sterilization.
Traceability - All sterilization lots must be traceable.
Effective sterilization management builds customer confidence
In the absence of sterilization, medical devices pose many different intolerable health risks. Deaths can result in cases of microorganisms that infect the human body. Therefore, the ISO technical committee correctly reviewed the current sterilization requirements in the previous version and added new controls in ISO 13485: 2016. Validation of sterilization processes - A procedure should be developed to address the validation of sterilization processes. Before proceeding with regular production, you must verify that this equipment will remove microorganisms from bio-contaminated vehicles.
For this reason, the sterilization process in order to ensure the same efficiency in each application
-The device used in sterilization
-The materials used in the process
-The process parameters (heat, humidity, pressure, time, ventilation)
-Antimicrobial activity
- Sustainability and reproducibility of the process
verification is required.
We provide services for creating and reporting protocols, procedures and instructions on how all these operations should be performed. We provide personnel trainings on the realization of sterilization validation process within your company.
Process Validation
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Packaging Validation
Sterile packaging must be verified for package safety. In the validation process;
- Installation and operation of the device used in sterile closure
-Compatibility and performance of packaging material
- Suitability and performance of the applied process
-Specific time protection performance of the product of the sterile package should be proved.
We set up procedures, instructions on how to perform packaging validation, and organize information and trainings on how much sample for which tests should be carried out in the light of sample selection criteria.
31AXX
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