ABSTRACT
@#Objective To establish CNC(controlled not classified)area microbial database of pharmaceutical enterprises,conduct correlation analysis with microbial distribution in clean area to achieve good microbial control in the clean area,especially in the core aseptic operation area,and improve the sterility assurance level of pharmaceutical enterprises.MethodsThe CNC area of a manufacturing workshop from pharmaceutical enterprise was selected as the research object,the airborne microbe,settling microbe,personal and environmental surface microorganisms were sampled one by one in the CNC area according to the route of personnel and materials entering the clean area. After the microorganisms were cultured and purified,the 16S rRNA sequencing method was used to identify the strains. Microbiomeanalyst online analysis software was used for data analysis.ResultsThe number of microorganisms in the CNC area of pharmaceutical enterprises was large and the species were rich. A total of 4 080 microorganisms were collected,which distributed in 47 genera. Gram-positive bacteria accounted for 84. 4%,mainly belonging to Staphylococcus,Micrococcus,Microbacterium. Gram-negative bacteria accounted for 15. 6%,and the distribution of Acinetobacter was much higher than other gram-negative bacteria. The Alpha diversity index was used to characterize the richness of microbial populations. The richness of microbial populations of airborne microbe and settling microbe was the highest,followed by environmental surface microorganisms,and the microbial population richness of personnel surface microorganism was the lowest. The number of microorganisms in the personnel's hood and chest was relatively small,and the number of microorganisms in the personnel's soles of feet and hands was relatively large. There were relatively few types of microorganisms on the surface of personnel,and staphylococcus showed an absolute advantage. The microbial distribution in CNC area was correlated with the microbial distribution in Class B and C clean areas of the same production workshop. Most of the microorganisms collected in Class B and C clean areas were included in the microbial population in CNC area. Class B and C clean areas were similar to CNC area,both of which were dominated by Staphylococcus and Micrococcus. The distribution proportion of Acinetobacter in Class B and C clean areas decreased compared with that in CNC area.ConclusionThe CNC area microbial database of the pharmaceutical enterprises has been established and the microbial population that is easy to enter the clean area has been determined,providing reliable technical support for the good microorganism control in the clean area
ABSTRACT
OBJECTIVE:To improve clean area environmental monitoring standards of Pharmacy intravenous admixture service (PIVAS)in hospital. METHODS:Referring to related national standards and specifications,combined with the work practice,the existing problems of environmental monitoring requirements in Quality Management Standard for Pharmacy Intravenous Admixture to clean area in PIVAS were explored. RESULTS:There was no provision on clean area environmental monitoring standards in Quality Management Standard for Pharmacy Intravenous Admixture;there was no specific numerical value of pressure difference, illumination and wind speed;there was no rule on airborne particles;there was no clear provision on settling microbe and airborne microbe;there was also no rules on the frequence of wind speed and airborne particles monitoring. CONCLUSIONS:Clean area environmental monitoring standards should be separately listed in Quality Management Standard for Pharmacy Intravenous Admix-ture,and clear provisions are given on detection method,monitoring project,judging standard and monitoring frequency,so that pharmacists are easy to operate and carry out.
ABSTRACT
Objective To analyze the factors affecting the cleanliness level and infection control in the clean area for pharmacy intravenous admixture service (PIVAS) based on continuous monitoring.Methods The cleanliness indexes such as suspended particle and settling bacteria,infection control indexes such as the hygiene of object surface and hand as well as the noise in the clean area for PIVAS from 2013 to 2016 were monitored continuously according to GB 50457-2008 Clean factory building design specifications of medical industry and Intravenous admixture quality control specification.Results All the indexes accorded with the requirements for cleanliness and infection control except some odd cases unqualified in hand hygiene.Suspended particles increased as the time went by,and decreased along with noise after replacing high-performance filter.Conclusion It's of great significance to qualify the clean area of PIVAS to maintain air conditioning purification system periodically,implement anti-infection measure strictly and standardize continuous monitoring and evaluation.
ABSTRACT
Objective To analyze the factors affecting the cleanliness level and infection control in the clean area for pharmacy intravenous admixture service (PIVAS) based on continuous monitoring.Methods The cleanliness indexes such as suspended particle and settling bacteria,infection control indexes such as the hygiene of object surface and hand as well as the noise in the clean area for PIVAS from 2013 to 2016 were monitored continuously according to GB 50457-2008 Clean factory building design specifications of medical industry and Intravenous admixture quality control specification.Results All the indexes accorded with the requirements for cleanliness and infection control except some odd cases unqualified in hand hygiene.Suspended particles increased as the time went by,and decreased along with noise after replacing high-performance filter.Conclusion It's of great significance to qualify the clean area of PIVAS to maintain air conditioning purification system periodically,implement anti-infection measure strictly and standardize continuous monitoring and evaluation.