Design and construction of purification workshop for liquid preparation production
Design and construction of purification workshop for liquid preparation production
Liquid preparation production workshop should be far away from highways, chimneys and other pollution sources with heavy dust generation and frequent traffic, and be located on the windward side of the dominant wind direction; the production workshop should be reasonably arranged according to the process requirements, and people and logistics should be separated; the purification workshop Walls, floors, ceilings...
Text label: liquid preparation purification pharmaceutical cleanroom, liquid preparation workshop design and construction, preparation workshop decoration company
Design and construction of purification pharmaceutical cleanroom for liquid preparation production
Liquid preparation production workshop should be far away from highways, chimneys and other pollution sources with heavy dust generation and frequent traffic, and be located on the windward side of the dominant wind direction; the production pharmaceutical cleanroom should be reasonably arranged according to the process requirements, and people and logistics should be separated; the purification workshop The walls, floors and ceilings are smooth and clean, without cracks, shedding particles and shells, and should not accumulate dust and mold; indoor hydropower process pipelines should be concealed; non-terminally sterilized oral liquid preparations, filtration, The minimum cleanliness level of the potting and sealing air is 100,000; the cleanliness level of the exposure process of the final treatment of the packaging materials in direct contact should be the same as that of the pharmaceutical production environment; steaming, frying, roasting, calcining, etc. The processing operations are carried out in production workshops that are suitable for their production scales, and have good ventilation, smoke removal, dust removal, cooling and other facilities; production equipment is adapted to production requirements, which is convenient for production operation, repair and maintenance.
The internal working conditions of the sterilization equipment are monitored by instruments, and the monitoring instruments are regularly calibrated and have complete records; the storage conditions of raw materials, auxiliary materials and packaging materials shall not make them damp, deteriorated, polluted or prone to errors; materials entering the control area, The outer packaging needs to be removed. If the outer packaging cannot be removed, it needs to be cleaned or replaced with an indoor packaging barrel, and sent into the room through the material channel; the preparation, filtration, filling, sealing, sterilization, packaging and other processes of liquid preparations are strictly In addition to the requirements of the prescription and process regulations, the preparation process must be cleaned in the batching pot, container and pipeline, and can only be carried out after the clearance certificate is obtained. The water used in the preparation process must be freshly prepared. The storage time of deionized water should not exceed 24H. If it exceeds 24H, it must be reprocessed before use. If compressed air or inert gas is used, it must also be purified before use. , If heating and heat preservation is required during the preparation process, it must be strictly heated to the specified temperature and kept for a specified time; The process should be recorded in a timely and correct manner and reviewed; the filtrate should be stored in a clean and airtight container and filled in time, and the product name, specification, batch number, production date, etc. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for liquid preparation production workshops and purification workshops.
Oral liquid preparation bottles should be dried and sterilized in time after being cleaned as required. The bottle washing and drying and sterilization equipment should be equipment that meets GMP standards. The sterilized glass bottles should be placed in a control that meets cleanliness requirements. It should be used up within 1 day in general. If it is stored for more than 1 day, it needs to be re-sterilized for use. If it exceeds 2 days, it should be re-washed and sterilized. Before filling the liquid medicine, the quality indicators such as the content, color and clarity of the fine filtrate should be checked, and the filling and sealing can only be carried out if they meet the requirements. The filling equipment, needles, pipes, etc. must be rinsed with fresh distilled water and boiled for sterilization; Generally, it should be filled and sealed on duty. If there are special circumstances, effective anti-pollution measures must be taken. The waiting time can be appropriately extended, but it cannot exceed 48H. The semi-finished product container that has been filled or filled and sealed should be placed in the production card. ; The operator must always check the quality of the semi-finished products after the sealing of the filling machine, and adjust the filling machine at any time to ensure that the difference in filling volume meets the requirements and the quality of filling and sealing; if the filling and sealing products need to be sterilized, the time from filling to sterilization should be It should be controlled within 12H, and the temperature, pressure and time of sterilization should be recorded in time during sterilization. After sterilization, vacuum leak detection should be carried out, and the vacuum degree should meet the specified requirements.
In today's world, have risen to an unexpected level of extraction machine. It has gained a lot of popularity and has come up with different kinds of variations in its content.
During SUZHOU PHARMA MACHINERY CO.,LTD.’s existence in a market we didn’t receive any negative feedback from our customers.
Once we have a good idea of how CUSTOM SOLUTION SERVICES can satisfy customer’s needs, consider whether we should create a skill for their demands.
CUSTOM SOLUTION SERVICES is receiving a great positive feedback in the market. And many of our clients are fully satisfied with it.
The manufacturing industry is changing fast, so, for SUZHOU PHARMA MACHINERY CO.,LTD., being able to pivot and adapt as the marketplace shifts is imperative.
In clean area management and quality control, laminar flow interference testing has received much attention, and whether it is only applicable to Class A laminar flow remains to be considered.