Select the right floating sampler to meet GMP regulatory requirements (portable and online)

　　Pharmaceutical Network Technical Article: The recommended limits for microbial monitoring during operation of clean areas, updated in January 2017, PIC/S Annex 1 have remained unchanged since 2003;
Table 1: pic/appendix 1 Recommended limits for microbial contamination (a) Note: (a) these are averages, and (b) a single settling plate can be exposed for less than 4 hours
Although these requirements have remained unchanged since 2003 from the point of view of the Pharmaceutical Manufacturing Quality Management Practices, many companies have received FDA 483 letters for microbial monitoring without air samplers;
FDA Warning Letter example (2016)"Air and urface ampling within all claified area i not adequate baed on the following: 1.Viable particulate ampling wa not conducted inide your Ante room, Gowning room, Buffer room and laminar flow hood during certification of thee above claified area."
First, what is the impact method doplankton sampling?
As shown in the figure, the active particles change as the flow of air flows, and large particles are hit on the culture base by inertia, while the smaller particles are taken away with the airflow Therefore, not all plankton samplers have the physical ability to hit as small particles as possible on the petri dish; however, increasing the flow rate of the sampled air may result in a decrease in particle survival due to mechanical damage or the fragmentation of bacteria or microfungal clusters (see Appendix B of ISO 14698-1)
Appendix B of ISO14698 is described below; the sampling rate makes a trade-off between the D50 value and the guarantee that the active particles will not be destroyed: II, what is the D50 value?
D50 value refers to the active particles through the floating bacteria sampler after large particles can hit the medium, and some particles with a particle size less than a certain value may have 50% of the active particles hit the medium, and 50% may be taken away with the air flow of small particle size Therefore, the D50 value is often regarded internationally as the resolution of the air sampler, i.e the particle size of small particles that the plankton sampler can physically capture
Third, physical acquisition efficiency: the ability of the sampler to collect particles of various sizes This efficiency is the same, whether it is active or inactive particles Physical efficiency depends on many factors, and the geometry of the sample head and the internal design of the air sampler, including the height of the medium, and even environmental conditions, can affect the physical efficiency Therefore, the third-party certification of the physical acquisition efficiency of the floating bacteria sampler is very important, and it represents the recognition of the sampling efficiency of this floating sampler
Fourth, biological acquisition efficiency: representing the ability of active particle collection The activity representing the acquisition process cannot be destroyed
ISO14698 Appendix B's description is as follows: Five, the selection of the sampler, selecting the appropriate phytoccal sampler needs to consider the following factors: the type and size of active particles to the sensitivity of active particles to the sampling process (whether it destroys the activity) The number of expected active particles Whether the flow measurement function of the floating bacteria sampler appropriate medium sampling time and duration In the sampling environment (e.g temperature) sampling The device's interference with the one-way airflow, the D50 value and the flow rate matching iVAS integrated phytobacteria sampler, designed for isolation afritriator amoeba sampling and portable phytoscal sampling, one sampler can do two types of flow (100L and 50L), and the D50 value is as low as 1.1 m
The iVAS Smart Phytostic Sampler has been certified for physical and biological acquisition efficiency testing by Salisbury Public Health In the United Kingdom
The standard modbu communication protocol allows for the integration of phytoplankton sampling systems, which increase particle monitoring: Shanghai Sein Intelligence Technology Co., Ltd provides professional particle monitoring system integration and wireless temperature and humidity monitoring;