The clean pipeline of pharmaceutical factory has the characteristics of strong professionalism and relative independence in the clean industry.
The machines and tools shall not damage the welded articles, and the operators must be trained and hold certificates; 2.
No incomplete penetration; Good linearity.
There shall be no oxidation on the inner surface.
The engineering machines and tools and manpower shall be configured according to the requirements of engineering quantity and engineering progress.
For example, water for injection can be kept warm for more than 70 °.
pickling and passivation of clean pipes of pharmaceutical factory.
The above cleaning, passivation and disinfection processes and their parameters shall be recorded.
The qualification criteria are: 1.
Aiming at the clean pipeline system of pharmaceutical factory, this paper mainly expounds several problems worthy of attention, such as standard types, construction process, pickling passivation, sterilization and verification of clean pipeline.
Inner wall of pipe RA ≤ 0.4 μ m； The polishing level of pure steam pipeline shall meet the requirements of outer wall RA ≤ 0.8 μ m.
5.
Safety protection articles must be provided during construction; 4.
In addition to strictly controlling the pipes, pipe fittings and valves to meet the requirements, special attention should be paid to the following two points in the construction preparation stage: during the welding process, the welding machine parameters should be adjusted through trial welding, and formal welding should be carried out on the premise that the test welding sample meets the requirements; After a group of welding is completed, the welding sample shall still be made, and the welding sample after construction shall maintain the same welding effect as the welding sample at the beginning of construction, then it can be considered that this welding meets the requirements.
The surface of clean pipelines shall be smooth, flat, easy to clean or disinfect, corrosion resistant, do not react with drugs or adsorb drugs, prevent microbial breeding and pollution, and ensure the quality and quality of drugs to the greatest extent.
3.2 construction preparation shall be carried out on the premise that the construction control system meets the requirements.
Sterilization: the treatment of killing or removing all microorganisms from the media.
The welded junction shall be etched or labeled after the completion of welding and passing the inspection by relevant personnel; See the following figure for label code: 3.5 precautions: 1.
Otherwise, check and confirm all welded junctions this time until the effect is met.
2.
Such as pure steam sterilization, pasteurization, peracetic acid and other chemical sterilization; The second is on-line sterilization: it is mainly used to sterilize the conveying, which generally will not affect the use in workshop production.
Pay attention to the sealing of the top plate of the purification room when entering the purification room; 7.
Inner wall of pipe RA ≤ 0.4 μ m； The polishing level of clean compressed air pipe shall meet the requirements of pipe outer wall RA ≤ 0.8 μ m.
There shall be no visible defects, defects, cracks, pores, slag inclusion, etc.; there shall be no spots and oxidation.
5、 Disinfection and sterilization of clean pipelines in pharmaceutical factories 5.1 sterilization of clean pipelines in pharmaceutical factories can be roughly divided into two categories: one is periodic disinfection and sterilization: generally, it is the disinfection and sterilization of storage tanks, process pipelines and water intakes of the system.
2.1 for several main clean pipes, the requirements for the polishing degree of stainless steel pipes are as follows: the polishing degree level of purified water pipes shall meet the outer wall RA ≤ 0.8 μ m.
Pharmaceutical water and raw water quality shall be regularly monitored and recorded.
At present, sanitary stainless steel pipe can well meet this requirement and is widely used.
2、 The standards and types of clean pipelines of pharmaceutical factories shall comply with the requirements of GMP standards.
From this definition, the two are different.
Superheated water and pure steam sterilization are considered as sterilization..
1、 Definition of clean pipeline of pharmaceutical factory the clean pipeline system of pharmaceutical factory is mainly used for the transportation and distribution of process water, gas and sterile clean materials, such as water for injection, purified water, pure steam, clean compressed air, etc.
4.
Such as ultraviolet, pasteurization, ozone sterilization, membrane filtration sterilization, etc.
During the whole process, it is forbidden to directly contact the welded articles with bare hands; 5.
3.3 the test welding sample shall be stored and the welded junction shall be subject to full appearance inspection.
3、 Clean pipeline construction of pharmaceutical factory 3.1 construction process when preparing the construction scheme, the secondary design shall be carried out according to the requirements of GMP certification on clean pipeline.
3.4 the weld crater identification shall minimize the number of on-site welding as much as possible Prefabrication can be completed in the purification room; The site welded junction shall be set at a position convenient for operation to facilitate automatic welding.
Inner wall of pipe RA ≤ 0.5 μ m； The polishing level of water for injection pipeline shall meet the requirements of outer wall RA ≤ 0.8 μ m.
Technicians must make technical disclosure to operators before construction; 3.
Final flushing: flush again until the resistivity of purified water at the inlet and outlet is the same.
Inner wall of pipe RA ≤ 0.5 μ m。 The outer diameter and wall thickness of sanitary stainless steel pipes of various standards are very different, which should be paid special attention and attention in the process of project implementation to avoid the mismatch of pipes, pipe fittings, valves and ferrules, which will not only cause construction difficulties, but also make the construction results fail to meet the requirements of GMP standards.
The preparation, storage and distribution of purified water and water for injection shall be able to prevent the breeding of microorganisms.
Code for quality management of pharmaceutical production (revised in 2010) It is stipulated that the materials used for purified water, water for injection storage tanks and transmission pipelines shall be non-toxic and corrosion-resistant; The vent of the storage tank shall be equipped with a hydrophobic sterilizing filter that does not shed fiber; Dead corners and blind pipes shall be avoided in the design and installation of pipelines.
The surface height shall not exceed 2 ~ 5% of the pipe thickness.
IV.
Welding logs and welding machine printing records need to be provided.
The construction shall be carried out in sections, and the ends of some constructed pipes must be sealed, and the pipe section shall be filled with argon for protection; 6.
The surface width shall be 2 ~ 3 times of the pipe thickness.
The pickling and passivation process of clean pipes of pharmaceutical factory is roughly as follows: pure water circulation pre flushing → alkali liquor circulation cleaning → purified water flushing → passivation → purified water re flushing → discharge initial cleaning: rinse with normal temperature passivation water for no less than 5min.
Therefore, ultraviolet, pasteurization and ozone can only be regarded as disinfection.
The definition of disinfection and sterilization in the 2002 disinfection technical specification of the Ministry of health: Disinfection: killing or removing pathogenic microorganisms on the transmission medium to achieve harmless treatment.
The inner side of the welded junction is straight and smooth, The outer annular ripple is uniform and beautiful (slight concavity or convexity is allowed); the weld crater on the whole circumference shall be formed uniformly.
3.
