[Original] Environmental Control of Powder Injection Rolling Cap Production Area-Wang Heng (Production Department)


Time:

2020-03-23

powder injection capping is to further ensure the effectiveness, safety and stability of drugs, so the capping is very important to ensure the quality of drugs. Providing a production environment that meets the requirements for the capping production area is a prerequisite for ensuring the quality of the capping. The powder injection rolling cover production area belongs to the B clean area, and the products before rolling cover are considered to be in an incomplete sealed state, so the B clean area in this state is the production area where the products in an incomplete sealed state are placed in a completely sealed container. The control of the regional environment is mainly elaborated from the following two aspects.

-, the design requirements of the plant

1 , the production area should have enough plane and space, enough places to reasonably place facilities and materials, and work in an orderly manner, so as to prevent mixing and cross-contamination between different drug intermediates and prevent the occurrence of accidents of missing any production or control steps. The area of the covered room should meet the following requirements: 1 , the area of the cleaning tool room 2 , the area of the processing and treatment area of the medicine bottle to be covered 3 , and the area of storing unqualified materials and intermediate products to be treated to avoid wrong feeding.

2 , the room should have anti-pollution measures, such as setting up necessary air lock, air shower room, buffer room and transmission window, etc. The material inlet should be set up separately, and the transmission route should be as short as possible. The inner surface (wall, floor, ceiling) of the rolling covered room should be flat and smooth, without cracks, tight interface, no particles and no shedding, avoid dust accumulation, facilitate effective cleaning, and should be disinfected when necessary. The junction of the wall, ceiling and floor should be made into an arc. The flow of people and logistics in

3 , rolling cover workshop is simple and reasonable, and the mixture of people and logistics is avoided. In order to prevent cross-contamination of people and logistics, the following measures are mainly taken, 1 , and people and things enter through separate doors. People flow, logistics entrance should be as few as possible, it is best to set up a people flow and logistics entrance, easy to control the cleanliness of the whole workshop. 2 , the changing room should be designed as an airlock, and the different changing stages can be separated to minimize the microbial and particulate contamination caused by clothing. 3 , delivery equipment used in pharmaceutical production shall not pass through workshops of different cleanliness levels.

2, workshop environmental control

1 , the design of the clean area must meet the corresponding cleanliness requirements, including reaching the "static" and "dynamic" standards.

The standards for all levels of airborne suspended particles are as follows:

cleanliness level

maximum allowable number of suspended particles / cubic meters

static

Dynamic

0.5 & micro; M

5 & micro; M

0.5 & micro; M

5 & micro; M

B

3520

29

352000

2900

C Level

352000

2900

3520000

29000

D

3520000

29000

is not specified

is not specified

2 , dynamic monitoring of suspended particles in the clean area

According to the level of the clean area and the results obtained in the verification of the air conditioning purification system and risk assessment, determine the location of the sampling point and conduct daily dynamic monitoring. The monitoring system for suspended particles should take into account the effect of the length of the tube used on the test results. Temperature and humidity also affect the nature of the product and operation.

3 , Microbial Monitoring

In order to evaluate the status of sterile microorganisms, dynamic monitoring of microorganisms should be carried out. The monitoring methods include sedimentation bacteria method, quantitative air planktonic sampling method and surface sampling method. Dynamic sampling should avoid adverse effects on clean areas.

# The dynamic standards for microbial detection in 263 clean areas are as follows ;

Level

Floating Bacterium

Cfu/m & sup3;

Sedimentation Bacteria

Cfu/4 Hours

Surface Microbe

Contact Disc

Cfu/ Disc

5 Glove

Cfu/ Glove

B Class

10

5

5

5

C

100

50

25

-

D Level

1000

100

50

-453

Gapping Production Workshop Environment Control Apart from Workshop Facilities, it also mainly depends on the workshop staff to actively and correctly operate in accordance with

SOP and abide by various regulations to ensure that the capping workshop environment meets the standards.