GAMP Group, We offerThermal validation with specialized expertise inComplete equipment Qualification of :
We are an Exclusive Partner of Amphenol Kaye - USA.
GAMP Group has Kaye Validators (10 AVS & 3 ValProbe Wireless System )for Advanced Thermal validation as well as temperature dry bath for Pre and Post calibration.
Our Validation team is well-versed in EN 285 guidelines and will collaborate with your team to determine the best approach for sterility assurance.
We offer Thermal Validation with Thermal Cycle Development, Steam Quality Test & Thermal Equipment and Qualification Documentation.
We use meticulously tested and calibrated equipment to guarantee precise results.
We arrive at your project equipped with the right tools, such as smart gaskets with sanitary fittings, feed-through mechanisms, and application-specific thermocouples (Teflon or Kapton). We also ensure the correct dry-block is selected before initiating your autoclave or sterilizer validation.
Steam Sterilization has been used for more than a century in the pharmaceutical and biotech industry to effectively sterilize products and materials withstanding moisture and higher temperatures.
Critical parameters such as Time, Temperature, Pressure, Direct Steam Contact, Air Removal have an impact on the sterilization results. Achieving Saturated Steam conditions is key and allows a proper temperature and pressure-controlled process.
Depending on the product and packaging characteristics different sterilization temperatures are utilized during Steam Sterilization Validation.
Autoclave Validation / Steam Sterilization Validation is one of the most critical and widely studied processes for the sterilization of drug products, liquids in sealed containers, and hard goods used in the testing or manufacturing of Pharmaceutical, Biotech, and Medical Device products.
The purpose of the Autoclave Validation / Steam Sterilization Validation process is to ensure the destruction of all bacteria, viruses, and other viable microorganisms. The destruction of a microbial population subjected to a sterilization process follows a logarithmic progression based on the Thermal Death Curve.
In the pharmaceutical industry, in order to define a unit as sterile, one must be able to certify that less than one unit in a million is exposed to the risk of not being sterile. The probability of finding a nonsterile unit (Probability of Non-Sterile Unit, or Sterility Assurance Level SAL) must therefore be smaller (as mathematical value) than 10−6.
The critical parameters that affect a successful Autoclave Validation / Steam Sterilization Validation are:
Regulatory requirements worldwide require the validation of all GMP Autoclaves and Steam Sterilization processes to provide documented evidence that the sterilization process, developed in process design, can reliably and repeatedly deliver the prescribed sterilization process as well as the attainment of the required Sterility Assurance Level SAL of the products.
Autoclave / Steam Sterilizer Validation can be divided into two main phases: Process Design and Process Qualification.
Process Design is the most critical part of Autoclave Validation / Steam Sterilization Validation as it directly impacts the ability of the sterilization process to repeatably deliver the desired results and quality attributes. Process Design needs to consider many variables such as:
Freeze-drying, also known as lyophilization, is a significant manufacturing process in the pharmaceutical and biotechnology sectors. This procedure is primarily applied to liquid products, transforming them into a stable, solid powder through sublimation. The process offers numerous benefits, notably extended shelf life and enhanced stability of the final product, significantly easing subsequent handling and storage.
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303-304, Sahyog Elina, VIP Main Road |
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+91 9879594538 |
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