Purified water systems and purified water distribution systems are mandatory inspection items in the technical review of medical mask product registration, so we must perfect the pure water system and design according to the 2015 Pharmacopoeia GMP guidelines. If the water purified system or purified water distribution system does not meet the necessary standards, extensive corrective work may be required at a later stage.
How to produce purified water that meets Pharmacopoeia GMP standards and use it in a mask factory? We give you the answer in this article.
1. What is Purified Water （Pharmacopoeia Water）Mean?
Ordinary water contains various ions, such as chloride ions, sodium ions, calcium and magnesium ions, etc. Purified water can be obtained from daily drinking water through distillation, ion exchange, reverse osmosis, and other water treatment processes. Purified water can be obtained by removing colloids, suspended solids, ions, microorganisms, and other substances in the water through pure water treatment equipment.
In the biopharmaceutical and pharmaceutical industries, companies using purified water equipment, such as mask factories, must strictly follow the purified water indicators specified in the pharmacopeia for process design and installation. In addition, companies also need to verify in accordance with GMP certification requirements.
The following table lists the explicit limits specified by the European Pharmacopoeia (Ph.Eur.), the United States Pharmacopoeia (USP), and the Chinese Pharmacopoeia (CP) for water quality at the point of use.
|United States Pharmacopeia||European Pharmacopoeia||Chinese Pharmacopoeia|
|TOC||ppm C||≤ 0.50||≤ 0.50||Same as European Pharmacopoeia|
|Conductivity||µS/cm||≤ 1.3 (25°C)||≤ 4.3 (20°C)||Same as European Pharmacopoeia|
|Nitrate (NO3)||–||≤ 0.2 ppm||≤ 0.000006%|
|heavy metal||–||≤ 0.1 ppm lead||≤ 0.00001%|
|Aerobic bacteria||CFU/ml||≤ 100||≤ 100||Same as European Pharmacopoeia|
2. How Does Water Purification Work?
The water purification system is roughly divided into 4 steps: pretreatment (primary purification), reverse osmosis (to produce pure water), ion exchange (to produce 18.2MΩ.cm ultrapure water), and terminal treatment (to produce ultrapure water that meets special requirements Ultra-pure water).
The pretreatment system usually consists of a sand filter, activated carbon filter, softened water filter and precision filter. When the raw water passes through the water filtration system, large particulate matter, residual chlorine and mineral ions in the water are removed, reducing damage to the reverse osmosis membrane and maximizing the role of the reverse osmosis equipment.
Reverse Osmosis System
Reverse osmosis can remove 90%-99% of pollutants and has high purification efficiency. Reverse osmosis membranes have extremely small pore sizes that allow only water to pass through.
The pretreated water enters the reverse osmosis equipment through a high-pressure pump. Water molecules are forced through the semipermeable membrane to the low-concentration side and filter out various soluble salts. thereby obtaining purified water.
Ion Exchange System
Deionized water usually means that the outlet water resistivity reaches 18.2MΩ at 25°C. cm of ultrapure water.
Removing ions through ion exchange system can theoretically remove almost all ionic substances. The principle of ion exchange is to replace unnecessary positive and negative ions in the water with H+ and OH- in the ion exchange resin, thereby achieving the purpose of purifying water.
With the development of technology, electrodeionization systems are gradually used in more fields. Purified water produced through the two-pass reverse osmosis (RO + RO ) + electrodeionization (EDI) process can meet the high-quality water needs of the pharmaceutical and pharmaceutical industry.
Usually, engineers will add other water treatment equipment at the end of the system to meet the customer’s special requirements. For example, ultrafiltration is used to remove heat sources, ultraviolet sterilizers are used to reduce total organic carbon (TOC) in water, microfiltration systems are used to remove bacteria, etc. to further produce ultra-low organic, sterile, pyrogen-free ultrapure water.
3. What are the Requirements for Purified Water in Mask Factories?
The medical purified water equipment in the mask workshop complies with the 2015 edition of the Pharmacopoeia GMP certification standard. The essential equipment for the production workshop of disposable medical masks and protective clothing – the two-pass reverse osmosis purified water equipment, from the water quality requirements, material requirements, and pipeline distribution, to ensure compliance with Certification standards.
According to the “Guiding Principles for Technical Review of Medical Mask Product Registration” issued by the National Bureau, based on the intended use and scope of application of the product, it is generally divided into medical protective masks, medical surgical masks, and disposable medical masks.
Purified water equipment for mask production workshops, and pure water machines for mask factories. Purified water equipment for masks conforms to GMP certification. Distribution pipeline SUS304/316L water point) medical disposable mask protective clothing production workshop, start-up type, small-scale research and development production enterprises, and other industries.
4. Designing a Purified Water System for a Mask Factory.
1）Standardized design: Purified water equipment is designed according to the latest Chinese, American, and European Pharmacopoeia standards, follows CGMP and GAMP specifications and meets GMP and FDA certification requirements.
2）Integrated design: More compact structure, easier operation, and maintenance.
3）Design according to URS: Only the purified water equipment system is customized and designed according to the needs of users. URS is the best!
5. NEWater Purified Water Equipment for Mask Factory.
|Name||Purified water machine for mask factory|
|Water production process||Two-stage reverse osmosis|
|Water production||0.5 tons/hour|
|Produced water quality||Conductivity ≤ 2us/cm (25℃ at room temperature）|
Sanitary components are used: sanitary membrane shells, clamps, storage tanks, and 304 sanitary pipes (depending on the user’s water quality requirements), and the inside of the pipes are not easy to breed bacteria, and single-sided welding and double-sided forming welding are adopted.
1. Sterile water tank: Equipped with rotary spray cleaning and air-breathing device.
2. Flow rate: Ensure turbulent flow in the circuit (flow rate greater than 1 m/s), maintain positive pressure in the circuit, and prevent microorganisms from staying, attaching, and breeding on the inner wall of the pipeline.
3. Pipelines and water storage points: The rubber pads in contact with purified water are all PTFE/EPDM. When the diaphragm valve is installed horizontally, it is 45 degrees. The installation of the circulation pipeline is set at a slope of 0.5%. Both the water tank and the pure water tank use stainless steel 304 sterile water tanks.
4. Disinfection and sterilization: Equipped with ozone sterilization and UV ultraviolet sterilizer to prevent bacteria from affecting water quality.
4）5 Characteristics of NEWater Pure Water Equipment System
– Complete set of configurations, integrated structure, small footprint, easy installation, and use.
– Advanced technology, reasonable design, continuous production of pure water, and no need for acid-base regeneration.
– The equipment has good performance, simple maintenance, and low operating costs.
– Fully automatic operation, with safety protection devices such as water shortage protection and low-pressure protection.
– Efficient water production, water quality up to standard, effective removal of heavy metals, viruses, bacteria, suspended solids, etc., water quality meets drinking pure water and a variety of industrial pure water.
6） NEWater Service
1. Contact customer service or business personnel for one-on-one detailed communication.
2. Engineers make plans and quotations according to customer needs.
3. Engineers communicate with customers on the plan and modify the plan.
4. Determine the plan and quotation, sign the contract, and produce.
5. After the installation and debugging are qualified, it can be accepted and used.
6. 1-year warranty and lifetime after-sales maintenance.
7）NEWater Purified Water System Applications.
- Chemical water treatment in power plants.
- Ultrapure water for electronics, semiconductor, and precision machinery industries.
- Preparation of food, beverages, and drinking water.
- Small pure water station.
- Community drinking pure water.
- Laboratory water.
- Process water for the pharmaceutical industry.
- Desalination of seawater, well water, and brackish water.
6. Final Words
As a comprehensive water system service provider, we focus on the design, production, supply, and maintenance of water system equipment. We have a professional and large-scale production and manufacturing base and a complete customer service system.
Our purified water equipment has been put into use in many countries and different application fields. If you want to know about purification water system projects and equipment on-site operation, please contact NEWater. NEWater strives to help your business maximize comprehensive value. One-to-one customized systems to meet your purified water equipment and purified water equipment needs.