The Difference between Medical Purification Room and Electronic Purification
The key technology of clean room in pharmaceutical factory is mainly to control dust and microorganism. As a pollutant, microorganism is the most important part of clean room environmental control in pharmaceutical factory. The contaminants accumulated in the equipment and pipes in the clean area of the pharmaceutical factory can directly pollute the medicine, but it does not affect the cleanliness test. So we say: GMP needs air purification technology, and air purification technology does not represent GMP! The cleanliness level is not suitable for characterizing the physical, chemical, radioactivity and life of suspended particles. It is a big misunderstanding of GMP to be unfamiliar with the production process and process of drugs, to know the causes of pollution and the places where pollutants accumulate, to master the methods and evaluation criteria of removing pollutants, and to think that a clean room meeting the requirements of cleanliness can produce high-quality drugs.
Based on my investigation and understanding of the environmental conditions in the clean areas of many pharmaceutical factories (which have been put into operation) in Northeast China, there are two common situations in GMP technical renovation of pharmaceutical factories:
(1) Due to the subjective misunderstanding and the unfavorable application of clean technology in the process of pollution control, the quality of drugs has not been significantly improved after some pharmaceutical factories invested huge amounts of money in the transformation.
The design, construction, manufacture and installation of equipment and facilities, raw and auxiliary materials for production, quality of packaging materials, and unfavorable execution of control procedures for net human and material facilities will all affect the product quality.
After analysis, I think that the reason that affects the quality of products in construction is that there are problems in the process control link, and there are hidden dangers in the process of installation and construction, which are as follows:
(1) The inner wall of the air duct of the purified air conditioning system is not clean, the connection is not tight, and the air leakage rate is too high;
(2) The enclosure structure of color steel plate is not tight, and the sealing measures of clean room and technical interlayer (ceiling) are improper, and the sealing door is not closed;
(3) Decorative profiles and process pipelines form dead corners and dust deposits in the clean room;
(4) Individual locations are not constructed in accordance with the design requirements and cannot meet the relevant requirements.
The quality of the sealant used is not satisfactory, easy to fall off and deteriorate.
_Return and exhaust air color steel plate are interlinked, dust from exhaust air to enter the return air duct;
_The inner wall welds of stainless steel sanitary pipes such as purified water and injection water were not formed during welding.
_The air duct check valve fails to operate and air backfilling causes pollution.
_The installation quality of drainage system is not up to standard, and the pipe racks and accessories are liable to accumulate dust.
_The setting of pressure difference in clean room is not up to standard and fails to meet the requirements of production process.
Therefore, for each professional installation engineering company, clean room engineering construction, whether high or low cleanliness, must do a good job for the pharmaceutical factory to control the process before the pollution source enters.
(2) The energy-saving effect of HVAC system in clean rooms of most pharmaceutical factories is poor, resulting in unnecessary expenditure and increasing the production cost of drugs.
For example, in some pharmaceutical factories, the cleanliness of the purification workshop is barely qualified when it is tested in the air or static state. Under the condition of dynamic testing (production), the cleanliness is not ideal. Therefore, it is necessary to set the frequency conversion speed regulation of air conditioning unit to Max working condition (so that the number of ventilation reaches the relative Zui value), so as to make the indoor cleanliness meet the requirements. The increase in the number of ventilation will inevitably lead to increased energy consumption, unnecessary expenditure and increased production costs of drugs.
In order to save initial investment, some pharmaceutical factory investors arbitrarily reduce the design requirements and purchase relatively inexpensive equipment, such as chillers, pumps, fans and pharmaceuticals. These seemingly inexpensive equipment are inefficient and quietly consume energy in vain, making the investors lose nothing.
In some process equipments, the exhaust air volume fluctuates greatly while the variable air volume exhaust fan is not used to save energy, and more exhaust heat is not recovered.
Ed Purification is a purification engineering company specializing in the design, construction, commissioning and installation of food aseptic workshop, GMP purification workshop, electronic dust-free workshop, food and pharmaceutical packaging workshop, medical equipment workshop, laboratory purification and other projects. To learn more about the medical purification industry, please pay attention to the Wechat Public No. Aide-188 (Ed Purification and Oxygen Supply)