Sampling operation is the first step of the whole laboratory testing process, but also the first important link that should be guaranteed, but also an important part of the quality control process.

 

If the sample is not representative, the analysis results cannot draw an accurate conclusion about the quality of the whole batch of product, and the sampling error will lead to the subsequent quality control process in a suspicious state. There is often this situation: the sample test results are abnormal, we have checked all aspects of the test process, there is no deviation, the result is that the sample has been contaminated when sampling. Such a situation is actually not uncommon, but how to eliminate it? Also have to start from the standard sampling operation, to do sterile sampling, to avoid cross contamination, to ensure that eliminate pollution from the source.

 

Principles and Procedures of Drug Sampling

 

The dilemma that pharmaceutical / food / cosmetics enterprises may face in the sampling process

 

lInuniform sampling is more complex

lCross-contamination with the sampling tools

lThe cost of sampler cleaning verification is relatively large

 

Resolvent:

A sterile disposable sample sampler ensures sample consistency that eliminates contaminants left in the reusable sampler

 

Drug Sampling Principles and Procedures require sampling tools with direct contact and drugs shall be cleaned and dried before and after use without chemical action and contamination; for sterile samples or microbial examination or bacterial endotoxin examination, the sampling tools shall be sterilized.

 

All tools and equipment must have cleaning procedures and records specified in writing; the cleaning procedures for sampling tools shall be valid. The purpose of GMP is to minimize the risks of contamination, cross-contamination, confusion and errors during drug production. The use of disposable sterile sampling tools increases the flexibility of sampling, reduces the workload of cleaning and verification, shortens the sampling time, and improves the work efficiency.



SP Bel-art is a Sterileware manufacturer that has been working in this field for more than 20 years, with the Bel-art Sterileware

family of products that are widely used in different sampling environments.




Application industry:

Pharmaceuticals: raw materials, process, testing, clean room manufacturing and testing, final products;

Chemistry: original product, production, final product testing;

Cosmetics: production, microbiological testing, final test;

Food and beverage: sampling, preparation, microbiological testing, online sampling, and final product;

Electronics: sampling, coating, plating;

Education and research, etc.

 

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Product superiority:

lReduce the risk of human error and sample contamination;

lMade of materials conforming to FDA and EU standards;

lGamma irradiation is sterile (SAL 10-6);

lStatement of TSE / BSE;

lSeparate packaging; lot marking for accurate tracking; sterilization certificate;

lCan provide double packaging, comfortable for high-level clean room;

lSome products are attached with stainless steel coating, which can be detected by standard metal detection and X-ray to avoid the possibility of mixing into the product.


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