Kaye Solutions for Washer Disinfectors

 Wireless

• Kaye ValProbe Wireless Process Validation

 Wireless

• Kaye ValProbe® RT (Real time RF)

Cleaning and Disinfection Processes: An Overview of Methods and Standards

Cleaning and disinfection processes are essential in the medical, pharmaceutical, and biotech industries. These processes are particularly used for cleaning and thermal disinfection of medical devices, instruments, and glassware. Thorough cleaning and disinfection are critical preliminary steps for subsequent sterilization methods such as steam or dry heat sterilization.

Adhering to specific parameters such as temperature and exposure time is crucial to ensure effective cleaning and surface decontamination. These parameters must be precisely monitored and controlled to ensure that all microorganisms and contaminants are removed. Documented protocoling of these critical process parameters is also essential during IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) of a new system and during the annual qualification and validation in a GxP environment. Whether it's a smaller lab-scale system or a large-scale pharmaceutical production facility, compliance with the standards applicable to this application is mandatory.

A typical example of this application is the pre-cleaning of glass vials before they are fed into a hot air tunnel. This pre-cleaning ensures that the vials are free from particles and other contaminants before being subjected to depyrogenation. Similarly, the qualification and validation of a stopper-washing machine in aseptic filling is a challenging task but crucial for maintaining sterile conditions.

As always in a GxP environment, adherence to standards and guidelines plays an important role in ensuring the effectiveness of cleaning and disinfection procedures. ISO 15883 (Washer-disinfectors) serves as an example of relevant standards defining requirements and testing procedures for these processes. Additional guidelines and regulations are also available for reference.

Kaye AVS and ValProbe-RT validation systems are ideal for the qualification and validation of cleaning and disinfection processes in a regulated GxP environment. Our innovative monitoring technologies ensure process safety and high operational efficiency, ultimately enhancing the quality and integrity of pharmaceutical products.

For more information about our products and solutions, please visit our website. We are happy to assist you with customized solutions for your specific requirements in the pharmaceutical and biotechnology sectors.

Kaye Solutions Dry Heat Sterilization

 Wired

• Kaye Validator AVS
• Accessories

 Wireless

• Kaye ValProbe Wireless Process Validation

 Wireless

• Kaye ValProbe® RT (Real time RF)

Hot Air Sterilization: An Overview of Methods and Standards

Hot air sterilization, also known as dry heat sterilization or depyrogenation, is a critical process for the removal of pyrogens and microorganisms from materials such as glassware and metal parts. This method is frequently used in the pharmaceutical and biotech industries and operates at high temperatures, typically up to 350+ ºC/ 662+°F or more. For effective sterilization, it is essential that both temperature and exposure time are precisely controlled to ensure the complete destruction of microorganisms.

The documentation of these parameters within the framework of IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) is important. These parameters must also be determined during the regular, annual qualification of the equipment according to existing norms and regulations in the GxP (Good Practice) area.

Static applications such as dry heat ovens provide a reliable method for sterilizing surgical instruments, glass vials, and other medical devices through the even distribution of hot air. This uniform temperature distribution is essential for an optimal sterilization outcome.

Continuous sterilization tunnels are another proven technology in hot air sterilization. They enable the continuous sterilization of products, such as vials, before they are fed into the filling line. This method offers efficient and safe sterilization, especially for large quantities.

For further information on normative requirements and guidelines, it is advisable to consult relevant ISO standards such as ISO 20857 (Sterilization of health care products – Dry heat – Requirements for the development, validation, and routine control of a sterilization process for medical devices) or other pertinent regulations as a basis.

The Kaye AVS (Automated Validation System) and ValProbe-RT validation systems are ideal for the qualification and validation of dry heat sterilizers, both in static applications and in sterilization tunnels. Our innovative monitoring technologies ensure process safety and high operational efficiency, ultimately enhancing the quality and integrity of pharmaceutical products.

For more information on our products and solutions, please visit our website. We are happy to assist you with customized solutions for your specific requirements in the pharmaceutical and biotechnology sectors.

Water-Cascade Sterilizer

Kaye Solutions for Water Cascade Autoclaves

 Wired

• Kaye Validator AVS
• Accessories

 Wireless

• Kaye ValProbe Wireless Process Validation

 Wireless

• Kaye ValProbe® RT (Real time RF)

Water Cascade Sterilization in Practice: Parameters, Process Design, and Challenges

Water Cascade or Waterfall Sterilizers are specialized moist heat sterilizers used for sterilizing temperature-sensitive products and materials. They allow for the elimination of germs and microorganisms without damaging the products through high temperatures. This method is mainly applied in the medical and pharmaceutical industries, as well as partially in food processing.

Principles of Water Cascade Sterilization:

The operation of these sterilizers is similar to steam sterilizers or autoclaves, with the main difference being the temperatures and cycle times used. While classical steam autoclaves typically reach temperatures between 121°C/ 250°F and 134°C/ 274°F, Water Cascade Sterilizers operate at lower temperatures, usually below 110°C/ 230°F.

Critical Sterilization Parameters:

• Temperature:
  Defining the exact temperature is crucial for the effectiveness of sterilization. This is achieved by hot water spraying over the objects to be sterilized.
• Time:
  Working at lower temperatures requires longer sterilization times to achieve the same microbial kill rate as higher temperatures.
• Pressure:
  During the sterilization process, an overpressure is generally maintained to ensure the penetration of hot water and uniform heat distribution.

Measurement and Control of Sterilization Parameters:

To ensure reliable and reproducible sterilization, temperature, time, and pressure must be continuously monitored and precisely controlled. These critical sterilization parameters must also be documented during Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as well as during regular annual qualification and validation to ensure compliance with applicable regulations. Standards such as ISO 17665-1 for moist heat sterilization and guidelines from the US FDA and the European Medicines Agency (EMA) must be considered.

Applications and Benefits:

Water Cascade Sterilizers are especially suitable for products that could be damaged by high temperatures. These include:

• Medical devices made of plastic
• Pharmaceutical products like nutrient solutions and eye drops
• Food packaging
• And many others

Thanks to the ability to use lower temperatures and longer sterilization cycles, Water Cascade Sterilizers offer a gentle and effective method for sterilizing temperature-sensitive products. The Kaye AVS and ValProbe-RT validation systems are ideal for the qualification and validation of Water Cascade Autoclaves and the sterilization of temperature-sensitive products with moist heat. These modern monitoring technologies ensure process safety and high operational efficiency, which ultimately enhances the quality and integrity of pharmaceutical products.

For more information about our products and solutions, please visit our website. We are happy to support you with tailored solutions for your specific requirements in the pharmaceutical and biotechnology industries.