1. Q: Is the purified water system and the water for injection system regularly disinfected with ultraviolet light? If not, what method should I use?
A: The “Good Manufacturing Practices for Pharmaceutical Production (Revised in 2010) requires companies to clean and disinfect purified water and water for injection pipelines without the mandatory method of disinfection. UV disinfection effects have many influencing factors, such as ultraviolet wavelength, intensity, irradiation time, water layer thickness, etc., which are difficult to control and can be used as an auxiliary means of disinfection.
There are multiple ways to disinfect the purified water system and water for injection. For example, the purified water system can be pasteurized or steam-sterilized, and the water for injection can be sterilized by pure steam or superheated. Ultraviolet light is only an auxiliary way to extend the disinfection cycle, but its effect is very limited.
Enterprises can determine the specific disinfection and sterilization methods according to their own equipment conditions and disinfection cycle, and fully verify them. However, in general, it is not recommended to use the method of regular disinfection of the purified water system and the water for injection system.
2. Ask, clean area monitoring, hemispherical camera cleaning is not clean every time, and the dead angle cleaning is not equal, very unsanitary and environmentally friendly, is there any good cleaning method?
A: For the clean area dedicated camera specially developed and produced in the clean room clean room, the special camera in the clean area is the special use environment of Weiyuan Tektronix for clean areas and clean rooms, especially for pharmaceutical factories, electronics factories, hospital operating rooms, food factories. A dedicated webcam developed by the clean room/sterile room/clean room. The camera can be seamlessly embedded in the color steel plate installation, the flat round outer surface is flush with the color steel plate, no sanitary corners, easy to clean and easy to disinfect. The camera can perform 24-hour fixed-point monitoring of key operations and key positions. The camera can be used in conjunction with the Weiyuan Tektronix OPCMES software to achieve clean zone monitoring and alarm events associated with video clips. As a production place for pharmaceutical companies, the clean area has strict regulations and requirements for the environment, dress and personnel flow. The operation of the clean room personnel cannot be fully monitored by a single hemispherical camera, and it is impossible to perform real-time fixed-point monitoring of the operating state and operation process of important equipment. How to realize the fixed-point real-time monitoring of key off-site and key equipment in the clean area?
In order to achieve multi-point monitoring between clean room operations, it is necessary to increase the number of surveillance cameras in the clean room under the current technical conditions. The hemispherical camera is mounted on the ceiling, the installation position is too high, the cleaning is inconvenient, and there is a sanitary corner, which increases the workload of cleaning and acceptance of the clean room.
The embedded dedicated camera in the clean area solves this problem. The embedded special camera in the clean area is installed on the color steel plate wall of the clean area, and is installed by inserting the color steel plate. The installation height is about the ceiling.
40-60cm. The plane of the camera is a pure flat plate. After being embedded in the color steel plate, the plane of the camera is flush with the plane of the color steel plate, and the cleaning of the camera is realized while cleaning the wall surface by using a wall wipe. At the same time, the pure flat panel of the camera has zero sanitary corners, and there is no situation where the cleaning is not in place.
Clean room clean room
3. Q: What are the monitoring standards and basis for the air cleanliness environmental parameters of clean production plants in pharmaceutical manufacturing enterprises? The "Good Manufacturing Practices (2010 Revision)" does not specify the technical standards for clean rooms, such as: the number of air changes, temperature , humidity, etc., then what standards should third parties use when confirming the cleanliness level of clean rooms?
A: Article 42 of the “Good Manufacturing Practices (Revised in 2010)†states: “The plant shall have appropriate lighting, temperature, humidity and ventilation to ensure that the quality of the products produced and stored and related equipment performance are not directly or Inter-grounding is affected." The company shall determine the temperature and humidity range of the clean zone based on the characteristics of the product and process.
Regarding the technical standards of clean rooms, there are many national standards involved in China, such as: "Code for the Design of Cleanrooms in the Pharmaceutical Industry" (GB50457-2008), "Code for Construction and Acceptance of Cleanrooms" (GB)
50591-2010) and so on. The detection methods of suspended particles, floating bacteria and sedimentation bacteria can refer to GB/T16292-2010, GB/T16293-2010, GB/T16294-2010 and other national standards.
ISO14644 also has a strong reference for the technical standards of clean rooms. In addition, the GMP Guidelines for Drugs prepared by the National Drug and Drug Administration of the State Food and Drug Administration also lists some requirements, such as the number of air changes.
D-level dynamic standard: 6-20 times/h; C-level dynamic standard: 20-40 times/h; B-level dynamic standard: 40-60 times/h.
4. Q: The specification requires dynamic monitoring of microorganisms in key operations. Does the floating bacteria need to be monitored dynamically throughout the process?
A: According to Article 11 of the Sterile Drugs in Appendix 1 of the Pharmaceutical Production Quality Management Regulations, microbiological monitoring should be carried out to assess the microbial status of aseptic production. Monitoring methods include sedimentation method, quantitative airborne bacteria sampling method and surface sampling method (such as cotton swab wiping method and contact dish method). Dynamic sampling should avoid adverse effects on the clean area. The review of the finished batch record should include the results of environmental monitoring.
The emphasis here is on the need for dynamic monitoring of the aseptic production environment to assess microbial status. This dynamic monitoring does not require a full process. The quality management regulations for pharmaceutical products also stipulate that "dynamic sampling should avoid adverse effects on clean areas." The company should evaluate the monitoring methods and procedures to be adopted. In particular, it is important to consider that the plankton sampling process and related interventions may have an impact on airflow organization in critical areas. Therefore, the dynamic monitoring of microorganisms in key operations does not require full dynamic monitoring of the floating bacteria.
5. Q: Is it necessary to test the residual amount of active ingredients during the cleaning verification of the special production equipment for raw materials (single variety)? Is it feasible to visually measure the residual non-visible materials?
A: Article 143 of the "Good Manufacturing Practices (2010 Revision)" stipulates that the cleaning method should be verified to verify its clean effect to effectively prevent pollution and cross-contamination.
Cleaning verification should take into account factors such as the use of the equipment, the cleaning and disinfecting agents used, the sampling method and location, and the corresponding sampling recovery, the nature and limits of the residue, and the sensitivity of the residue testing method.
The cleaning verification of special equipment in the production process of single-species APIs, from the perspective of risk, the active ingredient residues on special equipment have little effect on the quality of subsequent production products. The focus of the cleaning validation is to confirm the presence of residues of related impurities (degradation products, reactants) that ensure the safety and effectiveness of the drug.
If it is to produce a single type of special equipment, it should comprehensively evaluate the nature of the raw material drug (or intermediate) on the relevant equipment, whether there is high-activity impurities, whether the residue can be reached under the cleaning method. In general, cleaning verification needs to be proved by means of sampling and testing, and it is not possible to visually measure no visible residue as an indicator.
Visual inspection of residual non-visible materials is often used as a test standard after each cleaning action.
6. Q: The specification states that "the air cleanliness level of the sampling area should be consistent with the production requirements." How to understand "consistent with production requirements" is consistent with the production environment in which the materials will be used or in the environment in which the materials themselves are produced?
A: The complete requirement for the quality management of pharmaceutical production is that "Article 62 should normally have a separate material sampling area. The air cleanliness level of the sampling area should be consistent with the production requirements. If sampling in other areas or by other means, Can prevent pollution or cross-contamination."
The requirements for quality control practices for pharmaceutical production are to control the risk of contamination and cross-contamination introduced during the sampling process. From the perspective of risk, the sampling conditions are consistent with the production conditions of the sampled materials, and the risk of contamination and cross-contamination is not amplified. Therefore, the air cleanliness level of the sampling area should not be lower than the production conditions in which the sampled materials will be used. of.
7. Q: How do the cleanliness levels of washing, potting and ingredients of non-finalized small-volume injections be divided? Is the level of cleanliness between their auxiliary functions and their production operations the same? If the operation room is in the B-level background A level, can its auxiliary room be level B?
A: For the cleanliness level of each process step of non-final sterilization small-volume injection, Article 13 of Appendix 1 of the drug GMP gives an example. Non-terminally sterilized small-capacity injection bottle can be set at D level, potting In the A-grade under the B-level background, the sterilized and filtered liquid or product is formulated in Class C, and the sterile ingredients should be in Class A under the B-level background. The production operating environment for sterile pharmaceuticals can be selected with reference to this example.
It should be noted that the layout of the core area should be reasonable, and the settings between the auxiliary functions should be minimized. If the auxiliary room must be set, the impact on the core area should be minimized. The specific level of cleanliness of the ancillary rooms should be determined based on the operations performed in the room or the characteristics of the materials and utensils stored.
8. Q: Our company puts the dense and rare injections of small-volume injections and large-capacity injections in the C-class area, which improves the cleanliness level of the concentrated mixture. Is this feasible?
A: Whether it is feasible or not, it is necessary to consider whether the impact of the thickening process on the dilute process is acceptable, and whether measures can be taken to reduce the possibility of pollution and cross-contamination. For example, a large amount of material may be used in the process of concentration, and dust may be generated, which may cause pollution or cross-contamination (weighing, preparation, etc. of activated carbon). Companies should consider whether they can take steps to ensure that the risk of dust or cross-contamination is reduced to an acceptable level.
9. Q: There is no mention of "disinfectant rotation" in the specification. Does it mean that the disinfectant can not be rotated?
Answer: Article 43 of the Sterile Drugs of Appendix 1 of the Pharmaceutical Production Quality Management Regulations stipulates: "The clean area should be cleaned and disinfected according to the operating procedures. Under normal circumstances, the type of disinfectant used should be more than one. UV disinfection instead of chemical disinfection. Environmental monitoring should be carried out regularly to detect strains and pollution in a timely manner."
Although the quality control regulations for pharmaceutical production do not mandate that disinfectants must be rotated, they actually impose more scientific requirements on manufacturers. In the past, companies usually used disinfectant rotation according to requirements, and the effect of disinfectant rotation on the disinfection of clean areas was not studied. The newly revised drug GMP requires enterprises to conduct statistical analysis of environmental monitoring data to determine how to use no less than one type of disinfectant, and ultimately ensure the disinfection effectiveness of the disinfectant in the clean area.
10. Q: The specification requires that the pressure difference between the clean zone and the non-clean zone and the clean zone of different grades should be no less than 10 Pascal. If the core area of ​​production is Grade A, then from the core production zone A to the non-clean zone Is there at least a pressure difference of 40 Pascals? How to achieve it?
A: Yes. The air purification system can be designed by a professional design institute. On this basis, this requirement is achieved by the reasonable arrangement of the air supply volume and the return air volume and the difference in the number of air exchanges at different cleanliness levels.
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