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[质量保证QA] 日常环境监测,D级区是否有必要同时做沉降菌和浮游菌?还是二者选其一?

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药徒
发表于 2016-11-4 15:31:22 | 显示全部楼层
为什么不都做。又不是很麻烦。浮游菌有仪器,沉降菌摆在台面上就可以。
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药士
发表于 2017-1-2 22:40:46 | 显示全部楼层
本帖最后由 beiwei5du 于 2017-1-2 22:41 编辑
gudanxiaoai 发表于 2016-11-4 15:31
为什么不都做。又不是很麻烦。浮游菌有仪器,沉降菌摆在台面上就可以。

for you information!!
Two methods of Air sampling in a Clean Room
1. Air Samplers (active air sampling) – Air samplers draw in predetermined volumes of air. The air is drawn over a sterile media plate, which is later incubated to reveal the number of viable organisms per cubic feet or liter.  Currently agar impaction is the method of choice throughout the industries. Using a specially designed, and calibrated piece of equipment which holds the media plate under a perforated lid and draws in a known amount of air one can accurately measure the amount of viable bacteria within the air.
2. Settling plates (passive air sampling) - Petri dishes containing sterile growth media are exposed to the environment for a specific period of time, usually between 30-60 minutes but can be exposed up to four hours before compromising the integrity of the media itself.  Viable microorganisms which settle onto the media surface will grow after the plates are incubated.  However, passive air sampling is tending to be phased out because it does not reflect microbial contamination with an accurately measured volume of air.
选自:http://www.pharmpro.com/article/2010/05/environmental-monitoring-maintaining-clean-room
[size=0.8465em]PDA J Pharm Sci Technol. 2006 Nov-Dec;60(6):350-5.
Active air vs. passive air (settle plate) monitoring in routine environmental monitoring programs.[size=0.923em]Andon BM[size=0.8461em]1.
[size=13.9997px]Author information

Abstract
[size=1.04em]This article discusses the utility of active air versus passive air settle plate monitoring in a routine environmental monitoring program with an emphasis on the monitoring of the critical Grade A environments. It is recognized that there has been a long-standing historical use of settle plates in the pharmaceutical industry, and that European regulatory agencies have supported their use. However, current active air sampling technology can be more advantageous and effective in assessing airborne viable contamination in cleanrooms than settle plate monitoring. Given that both methods are designed to assess viable airborne contamination in cleanrooms, there may be no advantage in performing these two parallel methods for the detection of airborne contamination, especially if doing so increases the number of interventions into critical areas, which may in turn increase the risk of contamination without providing any added benefit in terms of data collection and/or process control. Therefore, the best use of settle plate monitoring may be as an optional test method for those applications where other, more efficient sampling methods may not be possible or may have limited applicability.


PMID: 17260900
[PubMed - indexed for MEDLINE]选自:https://www.ncbi.nlm.nih.gov/pubmed/17260900

图片选自PDA TR13 Environmmental Monitoring
其实感觉国外还是优先采取使用浮游菌检测的方法,其次才是沉降菌检测方法。
@江苏新征鸿净化 @石头968
viable particulates sampling methods.jpg
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药士
发表于 2017-1-2 23:24:10 | 显示全部楼层
仅供参考!!http://emtekair.com/blog/air-sampling-how-to-do-it-the-right-way/Air Sampling – How to do it the Right Way

Air sampling is a critical function of any Quality Control (QC) laboratory associated with a Pharmaceutical, Biotech, or healthcare facility, yet many QC personnel are unaware of the best methods of microbial air sampling for their particular needs. There are several mechanisms for sampling viable particulates out of the air, and different mechanisms benefit different testing requirements. One must first determine the type of sampling device and scheme, which fits their specific needs, then work with the available technologies that best suits them to meet their testing requirements.
If one is unclear on how to most effectively use a microbial air sampler or compressed gas monitoring system to ensure the safety and health of your employees and customers, it’s important to understand the types of microbial air sampling devices and their individual benefits.
Passive vs. Active
There are two primary methods for microbial air sampling: Active and Passive monitoring. In active monitoring, a microbial air sampler is used to force air into, or onto its collection medium (e.g., Petri Dish with nutrient agar based test media) over a specified period of time. The collected culture can then be incubated and analyzed (ie., count bacterial and/or fungal, colony forming units (CFU), and identify if required). In passive monitoring, settle plates (Petri dishes) are opened and exposed to the air for specified periods of time to determine what microbiological particles may be present in the environment, as they may settle out of the ambient air, and onto the media surface of the Petri Dish.. These plates are then incubated and analyzed.
Both passive and active monitoring have their own strengths and weaknesses. Passive monitoring is not aggressive and may miss critical microbes, but offers a lengthy (4-hour) sampling period, and a very low cost associated with it. Active monitoring requires equipment purchases, additional training, device qualification, and most devices offer a shorter sampling period (e.g., 10-minutes), which can be both a benefit, or a burden. But, active monitoring devices are more ideal for situations with low microbial concentration, which includes most clean rooms, since microbial contaminants will be less likely detected by passive monitoring.
With both Passive and Active monitoring, personel are required to physically start the process, set up the settling plate, or device, and remember to check samples in process, label, and submit the test plates for incubation and analysis. With the analysis, active monitoring will allow for both a quantitative and qualitative analyses of the sample, by allow the determination of contamination levels per volume of air sample, while with passive monitoring one can only obtain a qualitative analysis.
Because there is no standardized protocol for collecting air samples, it is difficult to determine whether one method is “better” than the other.
However, knowing the difference can help you determine which solution will work best in your work environment. It is also important to note that microbial air samplers will turn up different results within the same area, or room based on the time and activity of the room. As such, both “Dynamic” and “Static” condition monitoring data should be collected in an area, or room. If a sample is taken during a surgery, for example, it will likely show more microbial elements than air sampling done in the same room with fewer factors, such as personnel and equipment, contributing to the microbial population.
When it comes to air sampling, the best method is one that works best for you and suits your specific needs while keeping your employees and clients safe.www.emtekair.com

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药师
发表于 2017-1-3 08:13:37 | 显示全部楼层
beiwei5du 发表于 2017-1-2 22:40
for you information!!Two methods of Air sampling in a Clean Room1. Air Samplers (active air sampli ...

二选一
浮游菌更简单方便,更具有代表性吧
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药徒
发表于 2017-1-3 08:15:45 | 显示全部楼层
可以不做浮游菌的。
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药徒
发表于 2017-1-4 09:40:46 | 显示全部楼层
同意楼上的意见
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药徒
 楼主| 发表于 2017-3-10 19:48:39 | 显示全部楼层
beiwei5du 发表于 2017-1-2 22:40
for you information!!Two methods of Air sampling in a Clean Room1. Air Samplers (active air sampli ...

看了你的回复,我也觉得很有道理,如果是二选一,浮游菌采样更具有代表性
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药徒
发表于 2017-5-11 16:09:34 | 显示全部楼层
战斗的蟋蟀 发表于 2016-10-28 08:36
我们是周期性的一起做了

你好,我想问一下你们做沉降菌和浮游菌除了QC那边有检验记录外,QA这边有没有取样记录?
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药徒
发表于 2017-5-11 16:09:59 | 显示全部楼层

你好,我想问一下你们做沉降菌和浮游菌除了QC那边有检验记录外,QA这边有没有取样记录?
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药徒
发表于 2017-5-11 16:10:28 | 显示全部楼层
ywz 发表于 2016-10-28 09:55
非无菌制剂D级区浮游菌不用做,只做尘埃粒子和沉降菌。

你好,我想问一下你们做沉降菌和浮游菌除了QC那边有检验记录外,QA这边有没有取样记录?
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药徒
发表于 2017-5-12 08:20:43 | 显示全部楼层
风吹依笑 发表于 2017-5-11 16:09
你好,我想问一下你们做沉降菌和浮游菌除了QC那边有检验记录外,QA这边有没有取样记录?

没有,我们都是QC取样的
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药徒
发表于 2017-6-5 09:40:59 | 显示全部楼层
我们现在是同时都做
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发表于 2017-6-23 14:33:06 | 显示全部楼层
日常二选一有什么文件你可以作为参考吗?
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发表于 2017-6-26 14:50:36 | 显示全部楼层
平时选择其一就行,验证系统的时同时测就行。
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药士
发表于 2017-9-22 17:44:50 | 显示全部楼层
Dr Haefele also proposed a simplification for the microbiological environmental monitoring. Settle plates as well as microbial air sampling are required in Europe at the moment. According to Dr Haefele only the microbial air sampling should be compulsory whereas the use of settle plates should be optional or additional. The use of average values in the microbiological monitoring in the clean room should be dismissed. With the use of isolators with validated decontamination cycles the microbiological monitoring could be reduced to the essential pursuant to ICH Q9 Quality Risk Management.
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发表于 2019-3-1 15:18:02 | 显示全部楼层
学习了,同样的问题
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