目 录
Table of Contents

1. 目的： 3
1. Purpose:3

2. 范围： 3
2. Range: 3

3. 职责： 3
3. Responsibilities:3

4. 参考依据： 3
4. Reference basis: 3

5. 检测环境： 3
5. Detection environment: 3

6. 需氧菌总数、霉菌和酵母菌检测方法： 3
6. Total number of aerobic bacteria, mold and yeast detection methods: 3

6.1. 设备、试剂和试液： 3
6.1. Equipment, reagents and test solutions: 3

6.2. 检测方法： 4
6.2. Detection method:4

6.3. 结果与判定： 5
6.3. Results and Judgments: 5

7. 控制菌检测方法： 5
7. Control bacteria detection method: 5

7.1. 设备、试剂和试液： 5
7.1. Equipment, reagents and test solutions: 5

7.2. 检测方法： 5
7.2. Detection methods:5

7.3. 结果与判定： 8
7.3. Results and Judgments: 8

8. 附件： 9
8. Attachments: 9

9. 相关文件： 9
9. Related Documents:9

10. 变更记载： 9
10. Change Record: 9

目的：
Purpose:

建立微生物检验操作规程，使检验工作规范化和标准化。
Establish operating procedures for microbial testing to standardize and standardize the inspection work.

范围：
Scope:

本规程适用于安徽圣诺贝化学科技有限公司质检部微生物检验的操作。
This regulation is applicable to the operation of microbial inspection of the quality inspection department of Anhui Shengnuobei Chemical Technology Co., Ltd.

职责：
Responsibilities:

QC依据本标准进行检验，
QC is inspected according to this standard

QA按照本标准进行监督。
QA supervises in accordance with this standard.

参考依据：
Reference:

《中国药典》
Chinese Pharmacopoeia

USP

EP

检测环境：
Detection Environment:

微生物的检测应在环境洁净度D级下的局部洁净度A级的单向流空气区域中进行。检验全过程必须严格遵守无菌操作，防止再污染，防止污染的措施不得影响供试品中微生物的检出。单向流空气区域、工作台面及环境应定期进行洁净度验证。
The detection of microorganisms should be carried out in a unidirectional flow air area with local cleanliness class A under environmental cleanliness class D. The whole process of inspection must strictly comply with aseptic operation to prevent recontamination, and the measures to prevent contamination shall not affect the detection of microorganisms in the test sample. Cleanliness verification should be carried out regularly in unidirectional flow air areas, work surfaces and environments.

需氧菌总数、霉菌和酵母菌检测方法：
Total Aerobic Bacteria, Mold and Yeast Detection Methods:

设备、试剂和试液：
Equipment, Reagents, and Test Solutions:

设备：生化培养箱、霉菌培养箱、冰箱、恒温水浴锅、天平、均质器、振荡器、无菌吸管、无菌锥形瓶、无菌培养皿（直径90mm）、无菌量筒、放大镜或菌落计数器、立式压力蒸汽灭菌器；
Equipment: Biochemical incubator, mold incubator, freezer, thermostatic water bath, balance, homogenizer, shaker,Sterile pipette, sterile Erlenmeyer flask, sterile Petri dish (90 mm diameter), sterile graduated cylinder, magnifying glass or colony counter, vertical pressure steam sterilizer;

试剂和试液：胰酪大豆胨琼脂培养基、沙氏葡萄糖琼脂培养基、pH7.2无菌磷酸盐缓冲液、0.9%无菌氯化钠溶液。
Reagents and test solutions: tryptic soybean peptone agar medium, Sasharini glucose agar medium, pH7.2 sterile phosphate buffer, 0.9% sterile sodium chloride solution.

稀释液配制：
Diluent preparation:

pH7.2无菌磷酸盐缓冲液：量取0.2mol/L磷酸二氢钾溶液250ml，加0.2mol/L氢氧化钠溶液175ml，用水稀释至1000ml，摇匀，分装，灭菌。
pH7.2 sterile phosphate buffer: take 250ml of 0.2mol/L potassium dihydrogen phosphate solution and add 175ml of 0.2mol/L sodium hydroxide solution, dilute to 1000ml with water, shake well, aliquot, sterilize.

0.9%无菌氯化钠溶液：称取氯化钠9.0g，加水溶解使成1000ml，过滤，分装，灭菌。
0.9% sterile sodium chloride solution: weigh 9.0g of sodium chloride, add water to dissolve it into 1000ml, filterAliquot and sterilize.

1% 二盐酸N，N-二甲基对苯二胺试液：称取二盐酸N，N-二甲基对苯二胺0.1g，加水10ml溶解即得。需新鲜少量配制，于冷处避光保存，如试液变成红色，不可使用。
1% dihydrochloric acid N,N-dimethyl-p-phenylenediamine test solution: weigh dihydrochloric acid N,N-dimethyl-p-phenylenediamine 0.1g, add 10ml of water to dissolve. It needs to be prepared fresh and in small amounts, and stored in a cold place away from light, if the test solution turns red, it cannot be used.

检测方法：
Detection Method:

供试液的制备：
Preparation of test solution:

1:10的供试液：取10g/10ml/100cm²或SOP规定的适量供试品，置于盛有适量pH7.2磷酸盐缓冲液的无菌均质袋内，用拍击式均质器均质1min～2min，制备成1:10的供试液。取1ml 1:10的供试液，置于直径90mm的无菌平皿中，注入15-20ml温度不超过45℃熔化的胰酪大豆胨琼脂或沙氏葡萄糖琼脂培养基，混匀，凝固，倒置培养。每稀释级每种培养基制备2个平板。
1:10 test solution: take 10g/10ml/100cm2 or an appropriate amount of test sample specified by SOP, and place it in an appropriate amount of pH7.2In the sterile homogenization bag of phosphate buffer, homogenize with a tap homogenizer for 1min~2min to prepare a 1:10 test solution. Take 1ml of 1:10 test solution, put it in a sterile dish with a diameter of 90mm, and inject 15-20mlMelt the pancreatic casein peptone agar or Sashar's glucose agar medium at a temperature not exceeding 45 °C, mix, coagulate, and invert the culture. Prepare 2 plates of each medium per dilution level.

阴性对照试验：以稀释液代替供试液进行阴性对照试验，阴性对照试验应无菌生长。
Negative control test: The diluent is used instead of the test solution for the negative control test, and the negative control test should be aseptically grown.

培养和计数：胰酪大豆胨琼脂培养基平板用于需氧菌总数的计数，在30℃～35℃培养3～5天，沙氏葡萄糖琼脂培养基平板用于霉菌和酵母菌总数计数，在20℃～25℃培养5～7天，观察菌落生长情况，点计平板上生长的所有菌落数。菌落蔓延生长成片的平板不宜计数。点计菌落数后，计算各稀释级供试液的平均菌落数，按菌数报告规则报告菌数。若同稀释级两个平板的菌落数平均值不小于15，则两个平板的菌落数不能相差1倍或以上。
Culture and counting: Trypsin soybean peptone agar medium plates are used for counting the total number of aerobic bacteria, and are cultured at 30 °C~35 °CFor 3~5 days, Shassen's glucose agar medium plates were used for the total number of molds and yeasts to count, and were cultured at 20 °C~25 °CFor 5~7 days, observe the growth of colonies, and count the number of all colonies growing on the plate. Colonies that spread and grow into sheets should not be counted. After counting the number of colonies, the average number of colonies of the test solution of each dilution level was calculated, and the number of bacteria was reported according to the bacteria count reporting rules. If the average number of colonies of two plates of the same dilution grade is not less than 15, the number of colonies of the two plates cannot be 1 times or more different.

菌数报告规则
Bacterial count reporting rules

需氧菌总数测定宜选取平均菌落数小于300cfu的稀释级、霉菌和酵母菌总数测定宜选取平均菌落数小于100cfu的稀释级，作为菌数报告的依据。取最高的平均菌落数，计算1g、1ml或其它适量供试品中所含的微生物数。
The dilution grade with an average colony count of less than 300 cfu should be selected for the determination of the total number of aerobic bacteria, and the dilution grade with an average number of colonies less than 100 cfu should be selected for the determination of the total number of molds and yeasts as the basis for the bacterial count report. Take the highest average number of colonies, and calculate the number of microorganisms contained in 1g, 1ml or other appropriate amount of test samples.

如各稀释级的平板均无菌落生长，或仅最低稀释级的平板有菌落生长，但平均菌落数小于1时，以＜1乘以最低稀释倍数的值报告菌数。
If all plates of each dilution level are colony-free, or only the lowest dilution plate has colony growth, but the average number of colonies is less than 1, the number of bacteria is reported as <1 times the value of the lowest dilution factor.

结果与判定：符合各产品质量标准的要求。
Results and judgments: meet the requirements of various product quality standards.

控制菌检测方法：
Control Bacteria Detection Method:

设备、试剂和试液：
Equipment, Reagents, and Test Solutions:

设备：生化培养箱、霉菌培养箱、电热恒温培养箱、冰箱、恒温水浴锅、天平、均质器、振荡器、无菌吸管、无菌锥形瓶、无菌培养皿（直径90mm）、无菌量筒、放大镜、立式压力蒸汽灭菌器；
Equipment: biochemical incubator, mold incubator, electric constant temperature incubator, freezer, constant temperature water bath, balance, homogenizer, shaker, sterile pipette, sterile Erlenmeyer flask, sterile petri dish (diameter 90mm), sterile graduated cylinder, magnifying glass, vertical pressure steam sterilizer;

试剂和试液：胰酪大豆胨液体培养基、肠道菌增菌液体培养基、紫红胆盐葡萄糖琼脂培养基、麦康凯液体培养基、麦康凯琼脂培养基、溴化十六烷基三甲铵琼脂培养基、甘露醇氯化钠琼脂培养基、沙氏葡萄糖琼脂培养基、沙氏葡萄糖液体培养基、念珠菌显色培养基、pH7.2无菌磷酸盐缓冲液、0.9%无菌氯化钠溶液、1% 二盐酸N，N-二甲基对苯二胺试液。
Reagents and test solutions: pancreatic casein soybean peptone liquid medium, intestinal bacteria enrichment liquid medium, purple red bile salt glucose agar medium, McConkey liquid medium, McConkey agar medium, Cetyl trimonium bromide agar medium, mannitol sodium chloride agar medium, Sasharini glucose agar medium, Sasel's glucose liquid medium, Candida chromogenic medium, pH7.2Sterile phosphate buffered saline, 0.9% sterile sodium chloride solution, 1% dihydrochloride N,N-dimethyl-p-phenylenediamine test solution.

检测方法：
Detection Method:

耐胆盐革兰氏阴性菌：
Bile salt Gram-negative bacteria:

供试液制备和预培养：取各产品供试品10.0g，用胰酪大豆胨液体培养基作为稀释剂制成1:10供试液，混匀，在20〜25℃培养，培养时间应使供试品中的细菌充分恢复但不增殖(约2小时)。
Preparation and pre-culture of the test solution: take 10.0g of the test sample of each product, use the liquid medium of pancreatic soybean peptone as a diluent to make a 1:10 test solution, mix well, and use it in 20 to Incubate at 25 °C, the incubation time should allow the bacteria in the test sample to fully recover but not proliferate (about 2 hours) 。

取相当于lg供试品的上述预培养物接种至100ml肠道菌增菌液体培养基中，30〜35°C培养24〜48小时后，划线接种于紫红胆盐葡萄糖琼脂培养基平板上，30〜35°C培养18〜24小时。如果平板上有菌落生长，则判供试品有检出耐胆盐革兰阴性菌；如果平板上无菌落生长，则判供试品未检出耐胆盐革兰阴性菌。
The above pre-culture equivalent to LG of the test sample was inoculated into 100 ml of intestinal bacteria enrichment liquid medium, and incubated at 30 to 35 °C for 24 to After 48 hours, the streaks were inoculated on purple red bile salt glucose agar medium plates and incubated at 30 to 35 °C for 18 to 24 hours. If there is colony growth on the plate, it is judged that the test sample has detected bile salt-resistant gram-negative bacteria; If the plate grows without colonies, it is judged that the test sample is not detected with bile salt-resistant gram-negative bacteria.

阴性对照试验：以稀释液代替供试液进行阴性对照试验，阴性对照试验应无菌生长。
Negative control test: The diluent is used instead of the test solution for the negative control test, and the negative control test should be aseptically grown.

大肠埃希菌：
Escherichia coli:

供试液制备和增菌培养：取各产品供试品10.0g，用pH7.2无菌磷酸盐缓冲液作为稀释剂制成1:10供试液。取相当于1g供试品的供试液，接种至100ml的胰酪大豆胨液体培养基中，混匀，30〜35℃培养18〜24小时。
Preparation of test solution and enrichment culture: take 10.0g of test samples of each product, and use pH 7.2 sterile phosphate buffer as diluent to make 1:10 test solution. Take the test solution equivalent to 1g of the test sample, inoculate it into 100ml of liquid medium of pancreatic cheese soybean peptone, mix well, and 30 to 35 °CIncubate for 18 to 24 hours.

选择和分离培养：取上述培养物1ml接种至100ml麦康凯液体培养基中，42〜44℃培养24〜48小时。取麦康凯液体培养物划线接种于麦康凯琼脂培养基平板上，30〜35℃培养18〜72小时。
Select and isolate cultures: Take 1 ml of the above cultures and inoculate them into 100 ml of MacConkey liquid medium and incubate at 42 to 44 °C for 24 to 48Hour. The McConkey liquid culture was streaked and inoculated on a MacConkey agar medium plate and incubated at 30 to 35 °C for 18 to 72 hours.

结果判断：若麦康凯琼脂培养基平板上有菌落生长，则判供试品有检出大肠埃希菌；若麦康凯琼脂培养基平板上没有菌落生长，则判供试品未检出大肠埃希菌。
Results: If there is colony growth on the MacConkey agar medium plate, it is judged that Escherichia coli was detected in the test sample; If there is no colony growth on the MacConkey agar medium plate, it is judged that Escherichia coli was not detected in the test sample.

阴性对照试验：以稀释液代替供试液进行阴性对照试验，阴性对照试验应无菌生长。
Negative control test: The diluent is used instead of the test solution for the negative control test, and the negative control test should be aseptically grown.

铜绿假单胞菌：
Pseudomonas aeruginosa:

供试液制备和增菌培养：取各产品供试品10.0g，用pH7.2无菌磷酸盐缓冲液作为稀释剂制成1:10供试液。取相当于1g供试品的供试液，接种至适宜体积100ml的胰酪大豆胨液体培养基中，混匀。30〜35℃培养18〜24小时。
Preparation of test solution and enrichment culture: take 10.0g of test samples of each product, and use pH 7.2 sterile phosphate buffer as diluent to make 1:10 test solution. Take the test solution equivalent to 1g of the test sample, inoculate it into the liquid medium of 100ml of tryptic casein soybean peptone, and mix well. Incubate at 30 to 35 °C for 18 to 24 hours.

选择和分离培养：取上述培养物划线接种于溴化十六烷基三甲铵琼脂培养基平板上，30〜35℃培养18〜72小时，取上述平板上生长的菌落进行氧化酶试验。
Selection and separation culture: The above cultures were seeded on cetyl trimethylammonium bromide agar medium plates and incubated at 30 to 35 °C for 18 to 72 hoursColonies grown on the above plates were taken for oxidase assay.

氧化酶试验：将洁净滤纸片置于平皿内，用无菌玻棒取上述平板上生长的菌落涂于滤纸片上，滴加新配制的1% 二盐酸N，N-二甲基对苯二胺试液，在30秒内若培养物呈粉红色并逐渐变为紫红色为氧化酶试验阳性，否则为阴性。
Oxidase test: put the clean filter paper in a flat dish, take the colonies grown on the above plate with a sterile glass rod and coat it on the filter paper sheet, and add the newly prepared 1% N,N-dimethyl-p-phenylenediamine test solution dropwiseIf the culture is pink and gradually turns purplish-red within 30 seconds, the oxidase test is positive, otherwise it is negative.

结果判断：若溴化十六烷基三甲铵琼脂培养基平板上有菌落生长，且氧化酶试验阳性，则判供试品有检出铜绿假单胞菌。如果平板上没有菌落生长，或氧化酶试验阴性，则判供试品未检出铜绿假单胞菌。
Results: If there is colony growth on the cetyl trimonium bromide agar medium plate and the oxidase test is positive, it is judged that Pseudomonas aeruginosa was detected in the test sample. If there is no colony growth on the plate, or the oxidase test is negative, the test is judged to be undetected.

阴性对照试验：以稀释液代替供试液进行阴性对照试验，阴性对照试验应无菌生长。
Negative control test: The diluent is used instead of the test solution for the negative control test, and the negative control test should be aseptically grown.

金黄色葡萄球菌：
Staphylococcus aureus:

供试液制备和增菌培养：取各产品供试品10.0g，用pH7.2无菌磷酸盐缓冲液作为稀释剂制成1:10供试液。取相当于1g供试品的供试液，接种至100ml的胰酪大豆胨液体培养基中，混匀。30〜35℃培养18〜24小时。
Preparation of test solution and enrichment culture: take 10.0g of test samples of each product, and use pH 7.2 sterile phosphate buffer as diluent to make 1:10 test solution. Take the test solution equivalent to 1g of the test sample, inoculate it into 100ml of liquid medium of tryptic casein soybean peptone, and mix well. Incubate at 30 to 35 °C for 18 to 24 hours.

选择和分离培养：取上述培养物划线接种于甘露醇氯化钠琼脂培养基平板上，30〜35℃培养18〜72小时。
Selection and isolation culture: The above cultures were streaked and inoculated on mannitol sodium chloride agar medium plates and incubated at 30 to 35 °C for 18 to 72 hours.

结果判断：若甘露醇氯化钠琼脂培养基平板上有黄色菌落或外周有黄色环的白色菌落生长，则判供试品有检出金黄色葡萄球菌；若平板上没有与上述形态特征相符或疑似的菌落生长，则判供试品未检出金黄色葡萄球菌。
Results: If there are yellow colonies on the mannitol sodium chloride agar medium plate or white colonies with yellow rings on the periphery, it is judged that Staphylococcus aureus was detected in the test sample; If there is no colony growth on the plate that is consistent with the above morphological characteristics or is suspected, it is judged that no Staphylococcus aureus was detected in the test sample.

阴性对照试验：以稀释液代替供试液进行阴性对照试验，阴性对照试验应无菌生长。
Negative control test: The diluent is used instead of the test solution for the negative control test, and the negative control test should be aseptically grown.

白色念珠菌：
Candida albicans:

供试液制备和增菌培养：取各产品供试品10.0g，用pH7.2无菌磷酸盐缓冲液作为稀释剂制成1:10供试液。取相当于1g供试品的供试液，接种至100ml的沙氏葡萄糖液体培养基中，混匀，30〜35℃培养3〜5天。
Preparation of test solution and enrichment culture: take 10.0g of test samples of each product, and use pH 7.2 sterile phosphate buffer as diluent to make 1:10 test solution. Take the test solution equivalent to 1g of the test sample, inoculate it into 100ml of Shasser's glucose liquid medium, mix well, and incubate at 30 to 35 °C3〜5 days.

选择和分离：取上述预培养物划线接种于沙氏葡萄糖琼脂培养基平板上，30〜35℃培养24〜48小时。白色念珠菌在沙氏葡萄糖琼脂培养基上生长的菌落呈乳白色，偶见淡黄色，表面光滑有浓酵母气味，培养时间稍久则菌落增大，颜色变深、质地变硬或有皱褶。挑取疑似菌落接种至念珠菌显色培养基平板上，培养24〜48小时(必要时延长至72小时）。
Selection and separation: The above pre-cultures were streaked and inoculated on Shah's glucose agar medium plates, and incubated at 30 to 35 °C for 24 to 48Hour. The colonies of Candida albicans grown on Sassonii glucose agar medium are milky white, occasionally light yellow, smooth surface with strong yeast odor, and the colonies increase after a long incubation time, and the color becomes darker, the texture becomes hard or wrinkled. Pick suspected colonies and inoculate them onto Candida chromogenic medium plates and incubate for 24 to 48 hours (extended to 72 hours if necessary).

结果判断：若沙氏葡萄糖琼脂培养基平板上有疑似菌落生长，且疑似菌在念珠菌显色培养基平板上生长的菌落呈阳性反应，则判供试品有检出白色念珠菌；若沙氏葡萄糖琼脂培养基平板上没有菌落生长，或疑似菌在念珠菌显色培养基平板上生长的菌落呈阴性反应，则判供试品未检出白色念珠菌。
Results: If there is a suspected colony growth on the plate of Sasson's glucose agar medium, and the colony of the suspected bacteria growing on the plate of Candida chromogenic medium is positive, it is judged that Candida albicans was detected in the test sample; If there is no colony growth on the Sassoni glucose agar medium plate, or the colonies of suspected bacteria growing on the Candida chromogenic medium plate are negative, it is judged that the test sample has not detected Candida albicans.

阴性对照试验：以稀释液代替供试液进行阴性对照试验，阴性对照试验应无菌生长。
Negative control test: The diluent is used instead of the test solution for the negative control test, and the negative control test should be aseptically grown.

结果与判定：每克样品中应不得检出控制菌。
Results and Judgment: Control bacteria should not be detected in each gram of sample.

附件：
Attachments:

需氧菌总数、霉菌和酵母菌总数检验原始记录 SOP-QC/PS-039-R01-01
Total Aerobic Bacteria, Mold and Yeast Total Count Inspection Original Records SOP-QC/PS-039-R01-0 1

控制菌检验原始记录 SOP-QC/PS-039-R02-02
The original record of control bacteria inspection is SOP-QC/PS-039-R02-0 2

相关文件：无
Related Documents: None

变更记载：
Change Notes:

【需氧菌总数、霉菌和酵母菌总数】标准规定：需氧菌总数≤ cfu/（□g □ml □ cm²）
[Total number of aerobic bacteria, molds and yeasts] standard stipulates: the total number of aerobic bacteria≤cfu/(□g□ml □cm²）

霉菌和酵母菌总数≤ cfu/（□g □ml □ cm²）。
The total number of molds and yeasts ≤cfu/(□g□ml □^cm2).

仪器、试剂和试液：
Instruments, Reagents, and Test Solutions:

操作方法：
How it works:

供试液的制备：
Preparation of test solution:

1:10的供试液：取 （□g □ml □ cm²）供试品，置于盛有 ml pH7.2磷酸盐缓冲液的无菌均质袋内，用拍击式均质器均质1min～2min，制备成1:10的供试液。取1ml 1:10的供试液，置于直径90mm的无菌平皿中，注入15-20ml温度不超过45℃熔化的胰酪大豆胨琼脂或沙氏葡萄糖琼脂培养基，混匀，凝固，倒置培养。每稀释级每种培养基制备2个平板。
1:10 test solution: take (□g□ml □cm²) test sample and place it in a containerml of pH 7.2 phosphate buffer in a sterile homogenizing bag, homogenize with a tap homogenizer for 1min~2min, and prepare a 1:10 test solution. Take 1ml of 1:10 test solution, put it in a sterile dish with a diameter of 90mm, and inject 15-20ml at a temperature of no more than 45Melt pancreatic casein soybean peptone agar or sachsini glucose agar medium at °C, mix well, coagulate, and incubate incubate. Prepare 2 plates of each medium per dilution level.

阴性对照试验：以稀释液代替供试液进行阴性对照试验，阴性对照试验应无菌生长。
Negative control test: The diluent is used instead of the test solution for the negative control test, and the negative control test should be aseptically grown.

培养和计数：胰酪大豆胨琼脂培养基平板用于需氧菌总数的计数，在30℃～35℃培养3～5天，沙氏葡萄糖琼脂培养基平板用于霉菌和酵母菌总数计数，在20℃～25℃培养5～7天，观察菌落生长情况，点计平板上生长的所有菌落数。菌落蔓延生长成片的平板不宜计数。点计菌落数后，计算各稀释级供试液平均菌落数，按菌数报告规则报告菌数。若同稀释级两个平板的菌落数平均值不小于15，则两个平板的菌落数不能相差1倍或以上。
Culture and counting: Trypsin soybean peptone agar medium plates are used for counting the total number of aerobic bacteria, incubated at 30 °C~35 °C for 3~5 days, The Sashar glucose agar medium plate is used for the total number of molds and yeasts, incubated at 20 °C~25 °C for 5~7 days, the colony growth is observed, and the number of all colonies grown on the plate is counted. Colonies that spread and grow into sheets should not be counted. After counting the number of colonies, the average number of colonies of the test solution of each dilution level was calculated, and the number of bacteria was reported according to the bacteria number reporting rules. If the average number of colonies of two plates of the same dilution grade is not less than 15, the number of colonies of the two plates cannot be 1 times or more different.

菌数报告规则：需氧菌总数测定宜选取平均菌落数小于300cfu的稀释级、霉菌和酵母菌总数测定宜选取平均菌落数小于100cfu的稀释级，作为菌数报告的依据。取最高的平均菌落数，计算1g、1ml或其它适量供试品中所含的微生物数。
Bacteria count reporting rules: the dilution grade with an average colony number of less than 300 cfu should be selected for the determination of the total number of aerobic bacteria, and the dilution grade with an average number of colonies less than 100 cfu should be selected for the determination of the total number of molds and yeasts as the basis for the bacterial count report. Take the highest average number of colonies, and calculate the number of microorganisms contained in 1g, 1ml or other appropriate amount of test samples.

如各稀释级的平板均无菌落生长，或仅最低稀释级的平板有菌落生长，但平均菌落数小于1时，以＜1乘以最低稀释倍数的值报告菌数。
If all plates of each dilution level are colony-free, or only the lowest dilution plate has colony growth, but the average number of colonies is less than 1, the number of bacteria is reported as <1 times the value of the lowest dilution factor.

微生物计数：
microbial enumeration:

需氧菌总数：培养温度30～35℃
Total number of aerobic bacteria: incubation temperature 30~35 °C

霉菌/酵母菌总数：培养温度20～25℃
Total number of molds/yeasts: incubation temperature 20~25 °C

【控制菌】标准规定：每克样品中应不得检出控制菌。
The standard stipulates that control bacteria should not be detected in each gram of sample.

仪器、试剂和试液：
Instruments, Reagents, and Test Solutions:

耐胆盐革兰氏阴性菌：
Bile salt resistant gram-negative bacteria:

大肠埃希菌：
Escherichia coli:

铜绿假单胞菌：
Pseudomonas aeruginosa:

金黄色葡萄球菌：
Staphylococcus aureus:

白色念珠菌：
Candida albicans: