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SERVICES

Sanitek is ready to help you solve process filtration problems at any time!Better filtration solution with perfect membrane filters!

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Laboratory Technical Services

● Design of small sample test and microbiological filter system

The laboratory can conduct small sample test according to the customer’s material liquid in order to select the most efficient filter material composition andhelp the customer to choose the suitable microbiological filter and membrane filters to improve the production efficiency. At the same time, the laboratory can also provide customerswith a full set of membrane filters design services to help customers further improve production efficiency, taking into account the actual situation of customers.

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We fully understand the requirements and items that need to be confirmed and verified by the new GMP for sterilization microbiological filter under specific process filtration, and flexibly and organically combine GMP regulations, filter performance and production process filtration to quickly and easily provide customers with verification solutions for non-final sterilized products and final sterilizable products, sothat customers can successfully pass the GMP experts’ verification of filter compatibility.

Sanitek provides our customers with a quick and easy solution for the validation of non-final sterilizable products and final sterilizable products, so that they can successfully pass the GMP experts’ validationof filter compatibility.

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● Filter Performance Verification Service Program

Product Bacterial Viability

Many pharmaceuticals are bacteriostatic, and this test is used to confirm the viability of Pseudomonas spp. (ATCC® 19146TM) in pharmaceutical solutions under process conditions in order to select a suitable cleaning power profile and determine a reasonable bacterial challenge protocol.

Product wetting integrity testing

Under specified conditions, the forward flow, pressure retention, or bubble point limits of a filter wetted with a specific process fluid are measured to confirm that the filter integrity performance meets specifications.

Chemical compatibility assessment

Test the appearance, physical properties, bubble point, and diffusion flow changes of the process fluid to the filter before and after performing specific process conditions to examine whether cross-reactions between the filter and the process fluid are compatible.

Bacterial Challenge Study

Pseudomonas deficiency was used to evaluate the bacterial retention characteristics of three batches of filters by simulating specific process conditions online to meet a challenge level of 1 x 107 per square centimeter of effective filtration area at a concentration of less than 7 microbial log reduction.

Dissolved substance analysis testing

Testing filters for chemical substances that migrate into products under harsh conditions. In general, dissolved substances cannot be directly detected in the actual product and must be measured qualitatively and quantitatively by simulated solutions.

Verification test of cartridges after repeated use

According to ASTMF-838 standard, the bacteria retention test is conducted again on cartridges that have been subjected to multiple reuse and passed the complete part test.

Filter Performance Verification Service Program

● Filtration solution provider

Sanitek helps manufacturers, researchers and critical industries to solve filtration challenges. We have professional researching team to analyze and design microbiological filters and membrane filters for you.

When you need better filtration performance, want to get more accurate data and sterile final products, Sanitek is always ready to help you. Whenever youhave filtration challenges, please feel free to contact us, Sanitek will seek for a better solution for you!

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