Laboratory layout and operation

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[Abstract]:

The layout and design of the laboratory should consider good microbiological operation and safety. The essence is to minimize the cross-contamination of microbial strains, and the processing environment of microbial samples is also important, because the environment can also cause pollution.

In general, laboratories should be divided into clean areas, sterile areas and positive rooms. If possible, the surrounding environmental area of the treated and cultured sterile product should be completely separated from the positive area. However, it is impossible to completely separate the positive and clean areas, so it is necessary to take isolation and aseptic operations to reduce possible accidental contamination. These include: protective clothing, cleaning, disinfection procedures, and biosafety cabinets for clean and sterile use only. Procedures for spills and disasters caused by live strains should be placed on site and all relevant technicians trained in the above methods.

Microbial growth occurs in some samples and further analysis is required to determine the source of contamination. When bacteria are found to grow, the sample should be immediately transferred from the clean area to the positive area. Inoculation, staining, strain identification or other investigations should be performed in the laboratory's positive chamber. If possible, samples found to have colony growth cannot be opened in the clean area of the laboratory. Careful isolation of contaminated samples and materials will reduce false positive results.

Personnel undergoing sampling operations may not enter the positive room or operate in a positive room unless particularly careful, including wearing protective clothing and gloves, and carefully clean your hands after exiting. Ideally, when the authorized person performs a sample sampling operation, especially a sterile process, it cannot work near the positive operating room. Similarly, all microbial samples should be subjected to aseptic sampling techniques, including sampling of non-sterile samples. If possible, operate in the sampling area of the specified fully sterile conditions.

The main consideration is the contamination of the sample, which can lead to false positives unless special attention is paid to aseptic processing during the process. The sampling room should be designed so that the sampling of raw materials and excipients can be carried out under controlled conditions, including sterile clothing and sterile sampling equipment. Sampling of utility systems, such as water systems, is unlikely under fully sterile conditions; however, when samples are not sampled using aseptic techniques, they should be documented and their reliability inevitably decreases.

All tests in the laboratory, for critical test operations, such as: sterility testing of the final dosage form, bulk products, culture of bacterial species for biological products, or cell culture for biological products should be carried out under controlled conditions, isolated Technology is also available, sterile microbiological testing. It has been shown that isolation technology has a lower level of environmental pollution than artificial clean areas and, therefore, reduces false positive results.

Interpretation of microbiological test results

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Laboratory layout and operation