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Validation

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Validation Steam STERILIZATION PROCESS

The American Spice Trade Association (ASTA) developed the current white paper to assist the spice industry in validating microbial reduction techniques

Validation is a preemptive, or prospective, the exercise by which quality and safety are built into the product via controls in the manufacturing process that maximize the probability that the finished product meets the expectations of regulators and consumers.

Validation should focus on the critical control point(s) used to deliver the desired log reduction in Salmonella or another target organism

With more than 30 years of experience in this field, Eurofins Scientific offers a broad range of microbiological, bio-/chemical, and toxicological testing to examine products for the intended reprocessing procedures according to ASTA guidance requirement to validate procedures for manual and automatic cleaning, disinfection, and sterilization.

Eurofins Sac Ky Hai Dang is a member of Eurofins Scientific Group, established in 2015, formerly was Sac Ky Hai Dang Scientific and Technological Service Joint Stock Company.  We have 5 years’ experience record of performing the validation for the Steam sterilization process in Vietnam, Indonesia, the Philippines and Cambodia.

FDA Published guidelines

3 principal should involve validation process:

  1. To build sterility into a product.
  2. To demonstrate a maximum level of probability that sterilization methods have established sterility to all batches of the unit.
  3. To provide greater assurance of result of end-product sterility test.

Why choose Eurofins Sac Ky Hai Dang for validation for the Steam sterilization process?

  • Evaluate the effectiveness of your cleaning, disinfecting, and Steam sterilization protocols     
  • Identify critical point(s) on your instruments that represent worst-case challenges
  • Optimize your Instructions for Use
  • Complete your regulatory dossiers with proven validation reports
  • Minimize risk for introduction of filth throughout the production process
  • Prevent environmental contamination, cross-contamination, and post-processing contamination during processing and storage

Eurofins Sac Ky Hai Dang is an independent testing laboratory with more than 10 certificates from the BOA and the governmental competent authorities such as the Ministry of Health, Ministry of Agriculture and Rural Development, Ministry of Industry and Trade, Ministry of Natures Resources and Environment.

Eurofins Sac Ky Hai Dang (formerly known as Sac Ky Hai Dang) with more than 12 years of experience in testing service, we have:

  • High-level experts and technicians
  • State-of-the-art equipment and machinery
  • Focus on research and development
  • Apply information systems exclusively developed for Eurofins - LIMs (Laboratory Information Management Systems) through all stages in the Lab.
  • Service quality is our top priority and is always improved relentlessly under the supervision of European experts.

Moreover, Eurofins Sac Ky Hai Dang is a member of Eurofins Scientific, a network of more than 900 laboratories in 62 countries worldwide. Our experts always update the rules and regulations to advise the suitable analytical methods. We coordinate with the world’s leading contaminant analysis to provide optimal solutions to our customers. We offer to examine a large number of organic contaminants of anthropogenic origin, process contaminants, and migration residues, in a great variety of food and feed matrices with:

  • Accurate and reliable results.
  • Quality is the top concern.
  • Best service with flexible TAT (normal test, quick test, emergency test).
  • Diverse samples matrices.
  • Accurate and reliable results

FAQ

  • Which equipment needs to be validated?

    • The central sterile supply unit
    • Autoclaves and sterilizers
    • Medium and small sterilization equipment
    • Washing machines with the required temperature cycle
  • How often do I need to perform a validation?

Yearly is the minimum recommended time frame. We also advise performing a validation after major changes on the equipment or sterilization protocol.

  • Who can perform a validation?

    • A third party can guarantee total independence from manufacturer to user. The Laboratory has at least 10 years of experience in analyzing & testing for microbiological as local and international requirements.
    • Quality Management System: ISO 9001, ISO/IEC 17020,  ISO/IEC 17025

 

 

 

 

 

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