What is the basis for establishing standards for microbial testing laboratories?

Microbiological limit inspection laboratory and requirements: Microbiological limit inspection laboratory is used to check the degree of microbial contamination of non-designated sterilization preparations, raw materials and auxiliary materials. The inspection items include the number of bacteria, mold, yeast and controlled bacteria.

China Pharmacopoeia [1] requires laboratories to carry out microbial limit inspection. Microbial limit inspection should be carried out in one-way air area with local cleanliness of 1000 and environmental cleanliness of 1000. The whole inspection process must strictly abide by aseptic operation to prevent re-contamination. The cleanliness of one-way airflow area, table top and environment should be verified regularly according to the current national standards for testing methods of suspended particles, plankton and settling bacteria in clean rooms (areas) of pharmaceutical industry.

Commonly used instruments and equipment in microbial limit inspection laboratory

Instruments and equipment: 1, purification bench (vertical flow/horizontal flow) 2, constant temperature incubator (30 ~ 35℃)3, biochemical incubator (23 ~ 28℃)4, microwave oven 5, homogenizer (3000 ~ 8000 r/min) or Conor oscillator 6. 1 1 microporous membrane filter and membrane filter (microbial limit tester), 12 dust particle counter (with printing function), 13 planktonic bacteria sampling (slit type), 14 steam sterilizer (check the sterilization effect and ask relevant departments for verification regularly when using). 15 colony counter, 16 microscope (40× ~ 1500×), 17 electronic balance or drug balance (sensitivity 0. 1g), 18pH meter.

Glassware: 1, conical flask (250 ~ 300ml, 500ml contains some glass beads), 2, Petri dish (9cm), 3, measuring cylinder (1.0l, 500m 1), 4, test tube (/kloc-0) 10m 1 index 0. 1), 5, syringe (20ml or 30m 1), 6, applicator, 7, injection needle, 8, glass slide, 9, cover glass, 10, glass sterilization cylinder.

Glassware should be cleaned before use, and there should be no water drops hanging on the straws and measuring cylinders, and there should be no residual antibacterial substances. At a distance of 0.5cm from the upper end of the suction pipe, a proper amount of about 2cm of loose cotton is stuffed and put into the suction pipe barrel or kraft paper bag. Conical bottles, measuring cylinders and test tubes should be filled with cotton plugs or silicone plugs. If the suspension is prepared with an oscillator, the bottle stopper should be wrapped with cellophane to avoid contamination of the bottle stopper by the test solution during oscillation, and then wrapped with kraft paper. Glassware should be sterilized by 160℃ dry heat for 2h or 12 1℃ high pressure steam for 30min, and then dried for later use.

Appliance: large and small rubber heads (placed in a clean container with a lid and regularly soaked in 70% ~ 75% ethanol solution). Sterile clothes, hats, masks and gloves (prepared after washing and wrapped tightly in kraft paper) are disinfected for later use. Disposable sterile clothes, hats, masks and gloves can also be used.

Inoculation ring (white iridium or nickel-chromium alloy, ring diameter 4 ~ 5 mm, length 6 ~ 10 cm), alcohol lamp, alcohol cotton ball or iodophor cotton ball, sterilization scissors or scalpel, sterilization tweezers, sterilization steel cone, sterilization weighing paper, stainless steel medicine spoon, test tube rack, match, marker, white porcelain plate, wash basin and ceramic cover (60.

Inspection items of laboratory personnel in aseptic testing laboratory:

1 microbial count of purified water

2 coliform count of drinking water

3 Count of molds and yeasts in oral liquid preparations

4. Oral solid preparation auxiliary material control bacteria inspection

5. Bacterial control inspection of excipients for local administration.

6 Cleanliness detection of cleaning area

7 microbial limit test of oral liquid preparation

8 microbial limit test of oral solid preparation

9 microbial limit test of local administration preparation

10 Outward Bound Training Program

Items and requirements of microbial limit inspection

project name

work task

Knowledge target

capability goal

Microbial count of purified water

bacteria count

1, to understand the use of purified water in the production and inspection of biological products and drugs, microbial pollution sources and bacterial hazards;

2. Familiar with standard operating procedures; Pure water sampling;

3. Understand the basis for establishing internal control quality standards for purified water;

4, familiar with the conventional methods and application scope of bacterial count;

5, familiar with bacterial count data records, revision rules and reporting rules.

1, which can determine the sampling point and sampling amount of purified water according to regulations, and correctly prepare sampling equipment and samples;

2, according to the prescribed method and sample size to prepare bacteria counting vessels, culture medium, etc. ;

3. Purified water samples can be diluted, inoculated, cultivated, observed and recorded in accordance with the prescribed methods;

4, can correctly fill in the bacterial count operation record, and judge whether the water quality is in line with the regulations;

Number of molds

1, understand the harm of mold;

2. Familiar with the conventional methods and application scope of die counting;

3. Be familiar with the similarities and differences between mold counting method and bacteria counting method;

4. Be familiar with the difference between the rules for reporting the number of molds and bacteria.

1, you can refer to the operation method of die counting to complete the die counting operation;

2, can correctly fill in the mold counting operation record, and judge whether the water quality meets the requirements;

3. Able to operate microwave ovens and various sterilizers.

Detection of coliform bacteria in drinking water