VALIDATION

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DEVICE SETUP

SUITABILITY OF THE PACKAGING

Conformity of harmonised standarts

MEASURING THE PERFORMANCE OF THE STERILIZATION PACKAGE

Proof of protection performance

Product Cleaning Validation

There are many stages from medical devices, from the input of the raw material to the process and from the factory as the finished product. At these stages, contamination, residues and bioburden remain on the product due to contamination of the product, environmental conditions and operator. When it is aimed to reduce the bioburden by creating the necessary hygienic conditions; Controlled entrances to the production area, appropriate personnel equipment, hygiene procedures are important. In addition, product cleaning validation is vital to prove product safety, along with parameters, procedures and instructions for cleaning (washing) processes to remove dirt and debris left on the product.

Katsan provides medical device cleaning validation training with its experienced staff. It is also among the services to provide consultancy for the establishment and maintenance of the system

Sterilization Validation

Sterilization of medical devices is of great importance in the medical device industry. Medical Device Regulation, especially ISO 13485: 2016, and then Medical Device Regulation, gave great importance to sterilization. The sterile value of the product for each establishment in the chain (TC Ministry of Health, notified bodies, economic operators, surgical personnel) of the medical device to be placed on the market should be below a very small value such as 10-6 SAL. Otherwise, according to the Medical Devices Regulation, the release of medical devices to the market is stopped, the currently released medical devices can be withdrawn from the market and the manufacturer’s existing certificate (CE) can be canceled or suspended.

The safety of the product is proven by sterilization validation. The risk of placing the product on the market, which has undergone a validation sterilization process, comes with it. It may cause the surgeon to perform an additional operation to the patient or even cause infections that may result in death. The sterilization process prevents the transfer of microorganisms, bacteria to the patient and infection by ensuring the removal of contamination by killing the microorganisms on the product.

Some points highlighted in ISO 13485: 2016, the internationally recognized standard for sterilization requirements and how to comply:

  • (Article 3.20) Sterile Medical Device, the requirements of a medical device to be sterile may depend on applicable legal requirements or standards.
  • (6.4.2) Pollution control should plan and document arrangements for the control of the contaminated or potentially contaminated product to prevent contamination of the working environment, personnel or products. The manufacturer must document the requirements for the control of contamination with microorganisms or particulate matter for sterile medical devices and maintain the necessary cleaning during assembly or packaging.
  • (7.5.5) Special requirements for sterile medical devices; The organization must maintain the sterilization process parameters used for each sterilization batch. Sterilization records should be traceable to every production lot of medical devices.

 
Procedures and instructions need to be established for validation of sterilization processes. Before carried out regular production, verification is required to ensure sterility of the equipment used.

In order for the sterilization process to provide the same performance in each application, the following parameters must be verified;

  • Sterilization device
  • Process equipment and materials
  • Process parameters (temperature, humidity, pressure, duration, ventilation and drying)
  • Sustainability and repeatability of the process

Katsan, with its experienced team, provides training on all processes of sterilization validation and procedures related to procedures, instructions and reports in line with the extra demand.

Process Validation

Before release a new medical device into the market, the manufacturing processes of the manufacturers are safe; it must demonstrate that it has suitable arrangements to produce products for the specified user that meet technical and regulatory requirements. Manufacturers with ISO 13485 and FDA certification are required to verify their production processes. Here, process validation comes into play. Katsan provides training support on process validation processes.

Packaging Validation

Packaging is of great importance in sterile medical devices. Any tearing, puncturing, improper closure or easy opening results in impaired sterility of the product. Product safety is confirmed by packaging validation.

Katsan offers training services in accordance with the procedures and instructions regarding packaging validation. After validation, packaging validation reporting service is also provided in line with the demands of the manufacturers.