GMP-certified purified water equipment for the pharmaceutical industry
· Water quality complies with the 2000 version of the Pharmacopoeia standards and the provisions of the GMP
· Fully automatic operation of equipment and conditional automatic processing procedures (such as backwashing, regeneration, pickling, disinfection procedures)
· Monomer and pipeline equipment comply with GMP requirements (such as 316L material for back-end processing equipment such as sterilizer, membrane filter, terminal water tank and pipeline, and UPVC pipe for pipeline of pretreatment equipment)
Purified water quality standard
Resistivity: ≥0.5MΩ.CM, conductivity: ≤2μS
Ammonia ≤0.3μg/ml
Nitrate ≤0.06μg/ml
Heavy metal ≤0.5μg/ml
GMP certified pharmaceutical water requirements
One: GMP requirements for pharmaceutical water preparation equipment
1. The structural design should be simple, reliable, and easy to assemble and disassemble.
2. In order to facilitate the disassembly, replacement, and cleaning of parts, the design of the actuator is standardized, generalized, and systematically used as much as possible.
3, the inner and outer wall surface of the equipment, requires smooth and flat, no dead angle, easy to clean and sterilize. The surface of the part should be surface treated with chrome plating to resist corrosion and prevent rust. Avoid using paint outside the equipment to prevent peeling.
4. Preparation of purified water equipment should use low carbon stainless steel or other materials that have been verified to not pollute the water. Equipment for the preparation of purified water should be cleaned regularly and verified for cleaning results.
5. The materials in contact with the water for injection must be high-quality low-carbon stainless steel (such as 316L stainless steel) or other materials that have been verified to not pollute the water. Equipment for the preparation of water for injection should be cleaned regularly and verified for cleaning results.
6. The storage period of purified water should not be more than 24 hours. The storage tank should be made of stainless steel or other materials that have been verified to be non-toxic, corrosion-resistant and do not bleed out contaminated ions. The venting port should be protected by a hydrophobic sterilizing filter that does not shed fibers. The inner wall of the tank should be smooth, and the joints and welds should have no dead angles and trachoma. Sensors that display parameters such as liquid level and temperature pressure that do not form stagnant water contamination should be used. The storage tank should be cleaned, disinfected and sterilized regularly, and the cleaning and sterilization effects should be verified.
7. Delivery of pharmaceutical water
1) Purified water and pharmaceutical water should be transported by a stainless steel pump that is easy to disassemble and clean. Where purified water and water for injection are required to be compressed by compressed air or nitrogen, compressed air and nitrogen must be purified.
2) Purified water should be transported by circulating pipeline. The piping design should be simple and blind tubes and dead ends should be avoided. Pipes shall be made of stainless steel pipes or other pipes that have been verified to be non-toxic, corrosion-resistant and do not bleed out contaminated ions. The valve should be a hygienic valve with no dead angle, and the purified water should be marked with the flow direction.
3) Pipes and pumps for conveying purified water and water for injection should be cleaned, disinfected and sterilized regularly, and can be put into use after verification.
8. The design of the pressure vessel shall be undertaken by the licensed unit and qualified personnel, and shall be handled in accordance with the relevant provisions of the People's Republic of China National Standard "Steel Pressure Vessel" (GB150-80) and "Pressure Vessel Safety Technical Supervision Regulations". .
KN95 masks and other respiratory protection series
This category shows the KN95 and other respiratory protection product series produced by our company. It is a kind of Respiratory Protective Masks that our company mainly produces. At present, it mainly displays labor protection respiratory series. You can choose a variety of colors and Specifications, logo can be customized, welcome to buy and consult, we will welcome you with warm service
Dongying Hongxing Labor Protection Products Co., Ltd. was established in December 1995 with a registered capital of 300 million yuan and total assets of 230 million yuan. It has 520 employees, including 22 professional and technical personnel, with a sales volume of 280 million in 2019. Yuan is a private enterprise integrating R&D, production and sales of labor protection products. The company has a professional R&D team, standardized production lines and quality testing facilities. The company produces and operates more than 1,000 products in 30 categories, including Body Protective Clothing, etc., which can meet the comprehensive needs of labor protection from Head Protective Cap to Foot Protective Shoes , that is, labor protection from head to toe. The company has successively become a director unit of the Occupational Health Protection Products Committee of China Textile Business Association, a member unit of China Labor Protection Products Alliance, a member unit of Shandong Labor Protection Products Industry Association, and a top 50 enterprise in the national labor protection industry; Anbeier brand has become Shandong Labor Protection Products Industry Association Recommended Brand. Labor protection products such as Body Protective Clothing and Hand Protective Gloves produced by the company can meet the multi-faceted needs of laborers, and various Daily Washing And Chemical Articles can meet the all-round needs of various companies. Welcome to consult and purchase.
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Dongying Hong Xing Labor Protection Products Co.,Ltd. , https://www.hongxinglabor.com