Validation Services

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The cartridge verification items include but are not limited to:

1. Bacterial viability
To confirm the survival of defective Pseudomonas (ATCC, 19146TM) in process fluids.
Select appropriate cleaning methods (antimicrobial / bactericidal process fluids need to be considered) and determine reasonable bacterial retention options. The experiments included survival test and bacteriostatic / germicidal test.

 

2. Bacterial retention
Refer to the ASTM F-838 standard for on-line simulation of the worst process times of the actual production process.
To assess whether the bacterial retention characteristics of the 3 batch filters meet the effective filtration area per square centimeter (LRV) are not less than 7 of the standard requirement.
3. Chemical compatibility
After performing specific process conditions, test the influence of process fluid on the performance of the filter to examine the cross reactivity between the filter and the process fluid.
4, can extract
Test the removal of chemicals from a filter under harsh conditions.
5 、 leaching and adsorption experiments
After performing specific process conditions, the impact of the filter on the product quality is tested separately.
6, the integrity of the product wettability
Determination of the limit of foaming point and diffusion flow limit after wetting of the filter through a specific process fluid.
7. Bacterial retention after repeated use of the filter
According to the ASTM F-838 standard, the bacterial rejection performance of the filter after repeated maximum use was evaluated.

 


Technological process:

1. Fill out the product information questionnaire
2. Confirm the product information questionnaire
3. Send verification material
4, formulate verification program
5, the two sides confirmed that the contract
6. Implement verification report
7, both sides confirm the verification report
8. Issue verification report

Shanghai Jinke Filtration Equipment Co.,Ltd.
Add:Jinshan District Zhujing Town,shanghai Tingfeng Road ,
Lane4900,No. 23
Tel:021-57339181  
E-mail:peixianglong@foxmail.com

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