根據(jù)2015版《中國藥典》9203藥品微生物實驗室質(zhì)量管理指導原則，藥品微生物實驗室質(zhì)量管理指導原則包括以下幾個方面：人員、培養(yǎng)基、試劑、菌種、環(huán)境、設(shè)備、樣品、檢驗方法、污染廢棄物處理、檢測結(jié)果質(zhì)量保證和檢測過程質(zhì)量控制、實驗記錄、結(jié)果的判斷和檢測報告、文件等。以下具體介紹微生物實驗室環(huán)境要求。
微生物實驗室的整體布局應(yīng)滿足檢驗人員的工作需求，不得影響檢驗結(jié)果的準確性。工作區(qū)域與辦公區(qū)域應(yīng)明顯分開，避免環(huán)境混亂和污染，以提高微生物實驗室操作的可靠性。微生物實驗室應(yīng)配備獨立的空氣凈化系統(tǒng)，空氣過濾系統(tǒng)應(yīng)定期維護和更換。溫濕度的控制，壓力等都應(yīng)符合工作要求。并有相應(yīng)記錄的保存。
為降低環(huán)境交叉污染的風險，微生物實驗室應(yīng)明確劃分潔凈區(qū)域和活菌操作區(qū)域，活菌操作區(qū)應(yīng)配備生物安全柜，防止檢驗過程中有害生物因子對人員和環(huán)境造成危害。為確保各項工作在專屬區(qū)域內(nèi)進行，降低假陽性和假陰性結(jié)果出現(xiàn)的風險,無菌檢查應(yīng)在B級背景下的A級單向流潔凈區(qū)域或隔離系統(tǒng)中進行。在無菌區(qū)域內(nèi)不得打開任何出現(xiàn)微生物生長的培養(yǎng)物。微生物限度檢查應(yīng)在不低于D級背景下的B級單向流空氣區(qū)域內(nèi)進行。
微生物實驗室的潔凈級別按空氣懸浮粒子大小和數(shù)量的不同分為A、B、C、D 4個級別。具體分級標準如下：
各潔凈級別空氣懸浮粒子的標準
|
潔凈級別
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懸浮粒子最大允許數(shù)/立方米
|
|
靜態(tài)
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動態(tài)
|
|
≥0.5um
|
≥5.0um
|
≥0.5um
|
≥5.0um
|
|
A級
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3520
|
20
|
3520
|
20
|
|
B級
|
3520
|
29
|
352000
|
2900
|
|
C級
|
352000
|
2900
|
3520000
|
29000
|
|
D級
|
3520000
|
29000
|
不作規(guī)定
|
不作規(guī)定
|
實驗人員應(yīng)了解潔凈區(qū)域的正確進出程序，包括洗手流程、更衣流程。定期做潔凈區(qū)環(huán)境監(jiān)測工作，有效地控制和監(jiān)測潔凈區(qū)的環(huán)境。環(huán)境監(jiān)測項目應(yīng)包括懸浮粒子、浮游菌、沉降菌、表面微生物及物理參數(shù)。實驗室在使用前后應(yīng)進行清潔、消毒，并定期監(jiān)測消毒效果。
According to the 2015 edition of Chinese pharmacopoeia 9203 pharmaceutical microbiology laboratory quality management guidelines, pharmaceutical microbiology laboratory quality management guidelines include the following aspects: personnel, media, reagents, strains, environment, equipment, samples, test methods, pollution, waste management, quality assurance and quality inspection process quality control test results and experimental records, the judgment of the results and test reports, documents, etc. The following is a detailed introduction to the environmental requirements of the microbiological laboratory.
The overall layout of the microbiology laboratory shall meet the requirements of the inspection personnel and shall not affect the accuracy of the inspection results. The work area should be clearly separated from the office area to avoid environment chaos and pollution, so as to improve the reliability of microbiological laboratory operation. The microbiological laboratory shall be equipped with an independent air purification system, and the air filtration system shall be maintained and replaced regularly. Temperature and humidity control, pressure and so on should meet the work requirements. And records are kept.
To reduce the environmental risk of cross contamination, microbiology laboratory should be clearly divided clean area and the living bacterium operation area, living bacterium operation area should be equipped with biological safety cabinet, to prevent the harmful biological factors in the process of inspection cause harm to personnel and environment. To ensure all work carried out within the exclusive area, reduce the risk of false positive and false negative results, asepsis check should be under the background of B grade A uniflow clean areas or isolation system. No culture of microbial growth may be opened in a sterile area. Microbial limit checks should be carried out in a class B one-way flow air region, not less than D.
The cleanliness level of microbiology laboratory is divided into A, B, C and D according to the size and number of aerosol particles.
The experimenter should be aware of the correct procedures for entering and leaving the clean area, including the hand-washing process and the dressing process. Regular clean area environment monitoring work, effectively control and monitor the clean environment. Environmental monitoring projects should include suspended particles, plankton, sedimentation bacteria, surface microbe and physical parameters. The laboratory should clean and disinfect before and after use, and monitor the disinfection effect regularly.
