Bottled infusion GMP sterile workshop
Bottled infusion GMP sterile workshop
GMP workshop can sterilize large-volume injection bottled infusion, and its production process can include:
(1) Weighing
(2) Note that the cleanliness requirements are different at different stages of the concentrated preparation and the diluted preparation; at the same time, the concentrated preparation process has the process of adding activated carbon, at this time, attention should be paid to the problem of dust, and when adding carbon...
Text label: aseptic workshop for bottled infusion, GMP workshop for infusion
GMP sterile workshop for bottled infusion
GMP workshop can sterilize large-volume injection bottled infusion, and its production process can include:
(1) Weighing
(2) Note that the cleanliness requirements are different at different stages of concentrated and diluted preparation; at the same time, the concentrated preparation process involves the process of adding activated carbon. At this time, attention should be paid to the problem of dust, and a suction hood should be used at the carbon-added part. . According to GMP requirements, the environment that can be terminally sterilized is Class C, and the environment that is not terminally sterilized is Class A under Class B.
(3) Microporous membrane for filtration, requiring a C-level environment.
(4) Pay attention to the rough washing and fine washing when washing the bottle. Those that are not terminally sterilized are all grades A under grade B.
(5) Encapsulation Note that this is a key part to control cleanliness. For those that can be terminally sterilized, Class C or Class A under Class C (for wide-mouth bottles) is required. Non-terminally sterilized ones are grade A under grade B.
(6) Sterilization Since large infusions are easy to multiply bacteria and generate pyrogens, the process from filling to sterilization should be fast, and try not to exceed 4 hours; on the other hand, rubber stoppers are contaminated by microorganisms and pyrogens Another potential source, multiple cycles of washing and rinsing, with water for injection as a final wash; the time between washing and sterilization is reduced to a lower level as the humidity on the plug facilitates microbial growth and pyrogen generation Limits are also important.
(7) Sampling and sampling to check microorganisms and pyrogens.
(8) Light inspection to check the clarity.
(9) Packaging.
In order to reduce the pollution in the production process, the large infusion production equipment should have the ability to automate and continuous.
Key points of purification measures
(1) The cleanliness of the infusion GMP sterile workshop should be placed on the openings that are in direct contact with the product, and placed in the production line where the product is indoor air, such as bottle washing, bottle blowing, bottle transportation, etc., rather than requiring the entire workshop high cleanliness standards, and rubber stoppers and bottles are especially at risk from particles that are not washed or peeled off on their own. Zhongjing Global Purification can provide consulting, planning, design, construction, installation and transformation of sterile workshops and GMP workshops and other supporting services.
Therefore, ensuring the high cleanliness of the opening of the bottle and the thorough cleaning and the high cleanliness of the cleaning room and the bottle drying area are the key points of the purification measures in the infusion pharmaceutical cleanroom.
Of course, the sterilization of bottled infusion is also the key to product quality.
Because some infusions are infected with bacteria, they appear moldy, cloudy, turbid, and gas production, and some infusions contain a lot of bacteria, but there is no change in appearance. If this infusion is used, there will be serious consequences. The contamination of the infusion is mainly due to serious pollution in the production process, incomplete sterilization, loose stopper, and air leakage. In the process of infusion preparation, special attention should be paid to preventing contamination, because some spores need to pass 120 °C for 30~40min, and some actinomycetes need to pass 140 °C for 15~20min to kill. The more severe the contamination, the greater the likelihood of contamination by these heat-tolerant spores. Therefore, the fundamental solution is to minimize the pollution in the production process, and at the same time, strictly sterilize and pack tightly.
(2) One of the difficulties in the infusion workshop is the moisture problem.
This is mainly caused by steam overflow and ground water in the preparation process and sterilization process. Humidity will mainly cause the relative humidity of the air to increase, which can reach 80%~90%. For example, the humidity in the rubber stopper cooking room and the cleaning room is even higher. As a result, it will promote the growth of mold on the enclosure structure, equipment surface, etc., which is a serious threat. Infusion quality.
The method of eliminating steam overflow is also applicable to the principle of dust removal in powder injection workshop, which should focus on isolation and local exclusion. For the problem of water on the ground, firstly, reduce the running, running, dripping and leaking of equipment pipelines, secondly, delineate a special water operation area on the ground, surround the waterproof line, and apply anti-mold paint on the relevant surface for mold prevention. .
In order to prevent mold growth in the high-efficiency filter of the air supply outlet, a moisture-proof high-efficiency filter should be used. The filter adopts a metal or plastic frame, an aluminum foil separator, and a filter paper treated with glue.
(3) Prevent the pharmaceutical cleanroom temperature from being too high, which is a problem that is often overlooked. For example, in the dilute preparation pharmaceutical cleanroom, there is often a large container with a high temperature liquid of 80°C, and its outer surface temperature is as high as 50°C or more. Because the container is tall, its heat dissipation surface area can reach 10m2. Moreover, there is more than one such large container.
If the air supply volume of the clean workshop is calculated according to the cleanliness, it is generally smaller than that calculated according to the heat and humidity load. When air supply is carried out with the number of air changes at this cleanliness level, it is not enough to eliminate the residual heat and residual humidity in the workshop. As a result, the temperature of the workshop is often too high, and due to the humidity, the workshop will make people feel stuffy. a feeling of.
Therefore, for such a large infusion workshop with a large amount of residual heat and residual humidity, the air supply volume must be checked with heat and humidity loads.
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