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Leonard Industrial is with more than 15years experience for designing, manufacturing and delivering of water treatment and beverage filling packing machineries, we can provide complete solution of bottle mineral water and beverage factory plant including workshop GMP area construction. Now GMP designing and construction is our new extend business for supplying complete plant of customer who have full dependence for us. We can get most competitive direct channel price from original manufacturers of GMP materials locating all area of China to deliver together by us and built professional team for GMP work-shop designing and installation. We are professional solution provider for GMP Clean System projects, we can represent high quality and professional standard for China GMP clean room project and related equipment. We insist principle of "win-win business" and "exceed expectation" to serve our customers, and keeping our business idea of "integrity management, intentions services and small profits but quick returns" for our marketing process. We have professional design team and installation team for providing complete solution for GMP workshop designing, construction and operation for different industries regarding Food & Beverage Products, Electronic Items, Photoelectricity Products, Medical Products, laboratory and Hospital Operating Room. We do most suitable customize design for each GMP clean workshop based on customer's actual requirement and different factory location and actual setting.
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  • Pharmaceutical High Purity Water System China This guide discusses, primarily from a microbiological aspect, the review and evaluation of high purity water systems that are used for the manufacture of drug products and drug substances. It also includes a review of the design of the various types of systems and some of the problems that have been associated with these systems. As with other guides, it is not all-inclusive, but provides background and guidance for the review and evaluation of high purity water systems. The Guide To Inspections of Microbiological Pharmaceutical Quality Control Laboratories (May, 1993) provides additional guidance. Pharmaceutical High Purity Water System China For some ophthalmic products, such as the ophthalmic irrigating solution, and some inhalation products, such as Sterile Water for Inhalation, where there are pyrogen specifications, it is expected that Water for Injection be used in their formulation. However, for most inhalation and ophthalmic products, purified water is used in their formulation. This also applies to topicals, cosmetics and oral products. A basic reference used for the validation of high purity water systems is the Parenteral Drug Association Technical Report No. 4 titled, "Design Concepts for the Validation of a Water for Injection System." The introduction provides guidance and states that, "Validation often involves the use of an appropriate challenge. In this situation, it would be undesirable to introduce microorganisms into an on-line system; therefore, reliance is placed on periodic testing for microbiological quality and on the installation of monitoring equipment at specific checkpoints to ensure that the total system is operating properly and continuously fulfilling its intended function." Pharmaceutical High Purity Water System China
  • Insdustry GMP Clean Room Recommended level:100-100,000 Medical device GMP clean workshop: refers to the clean room that meets the production requirements of class II and class III medical device according to the requirements of the regulations on the supervision and administration of medical devices and the production quality management standards of medical devices. 1) The structure part generally purifies the workshop wall.Top plate is generally made of 50mm thick sandwich color steel plate.Its characteristic is beautiful, rigidity is strong, heat preservation performance is good, easy construction. Circular arc corner, door, window frame and other general use of special purification special profile manufacturing. 2) Floor can choose epoxy floor or high - grade wear - resistant plastic floor, if have antistatic requirement, can choose antistatic type. 3) The air return pipe is made of hot transfer zinc plate and pasted with the flame retardant PF foamed plastic sheet with good purification and insulation effect. 4) The high-efficiency air supply port is generally cut and welded into static pressure box with cold-rolled plate and then sprayed plastic treatment, then inlaid and fixed high efficiency filter, beautiful and clean, punching mesh plate with baking paint aluminum plate, no rust and no dust, suitable for cleaning Insdustry GMP Clean Room
  • Clean Room Construction Materials level:100-100,000 Medical device GMP clean workshop: refers to the clean room that meets the production requirements of class II and class III medical device according to the requirements of the regulations on the supervision and administration of medical devices and the production quality management standards of medical devices. 1) The structure part generally purifies the workshop wall.Top plate is generally made of 50mm thick sandwich color steel plate.Its characteristic is beautiful, rigidity is strong, heat preservation performance is good, easy construction. Circular arc corner, door, window frame and other general use of special purification special profile manufacturing. 2) Floor can choose epoxy floor or high - grade wear - resistant plastic floor, if have antistatic requirement, can choose antistatic type. 3) The air return pipe is made of hot transfer zinc plate and pasted with the flame retardant PF foamed plastic sheet with good purification and insulation effect. 4) The high-efficiency air supply port is generally cut and welded into static pressure box with cold-rolled plate and then sprayed plastic treatment, then inlaid and fixed high efficiency filter, beautiful and clean, punching mesh plate with baking paint aluminum plate, no rust and no dust, suitable for cleaning. 2. The dust-free medical equipment factory not only has high equipment cost, complex production process, high requirements on cleanliness and sterility, but also has strict requirements on the quality of production personnel. 3. Potential biological hazards will occur in the production process, mainly including (risk of infection, toxicity, sensitization and other biological reactions caused by dead bacteria or dead cells and components or metabolism to human body and other organisms, toxicity, sensitization and other biological reactions of products, and environmental effects). 4. Clean Area: the room (Area) that needs to control dust particles and microbial pollution in the environment. Its building structure, equipment and use all have the function of preventing the introduction, generation and retention of pollutants in the Area. 5. Air Lock: an isolated space with two or more doors set between two or more rooms (such as rooms with different cleanliness levels).The purpose of setting the air lock is to control the airflow while the personnel or material is in and out.The air lock is divided into personnel air lock and material air lock. 6. The basic characteristics of clean workshop for medical equipment: dust particles and microorganisms must be taken as environmental control objects. 7. The cleanliness of medical equipment production workshop is divided into four levels: local level 100, level 1000, level 10000 and level 30000 under the background of level 100 or level 10000. 8. Clean room temperature: without special requirements, in 18 to 26 degrees, relative humidity control in 45 to 65 percent. 9. Pollution control of clean workshop of medical equipment: pollution source control, diffusion process control, cross pollution control. Clean Room Construction Materials
  • Water For Injection Systems Water For Injection Systems Regarding microbiological results, for Water For Injection, it is expected that they be essentially sterile. Since sampling frequently is performed in non-sterile areas and is not truly aseptic, occasional low level counts due to sampling errors may occur. Agency policy is that less than 10 CFU/100ml is an acceptable action limit. None of the limits for water are pass/fail limits. All limits are action limits. When action limits are exceeded the firm must investigate the cause of the problem, take action to correct the problem and assess the impact of the microbial contamination on products manufactured with the water and document the results of their investigation. With regard to sample size, 100 - 300 mL is preferred when sampling Water for Injection systems. Sample volumes less than 100 mL are unacceptable. The real concern in WFI is endotoxins. Because WFI can pass the LAL endotoxin test and still fail the above microbial action limit, it is important to monitor WFI systems for both endotoxins and microorganisms. Pretreatment of feedwater is recommended by most manufacturers of distillation equipment and is definitely required for RO units. The incoming feedwater quality may fluctuate during the life of the system depending upon seasonal variations and other external factors beyond the control of the pharmaceutical facility. For example, in the spring (at least in the N.E.), increases in gram negative organisms have been known. Also, new construction or fires can cause a depletion of water stores in old mains which can cause an influx of heavily contaminated water of a different flora. A water system should be designed to operate within these anticipated extremes. Obviously, the only way to know the extremes is to periodically monitor feedwater. If the feedwater is from a municipal water system, reports from the municipality testing can be used in lieu of in-house testing. V. STILL Figures 3-5 represent a typical basic diagram of a WFI system. Most of the new systems now use multi-effect stills. In some of the facilities, there has been evidence of endotoxin contamination. In one system this occurred, due to malfunction of the feedwater valve and level control in the still which resulted in droplets of feedwater being carried over in the distillate. Water For Injection Systems
  • High Purity Water System This guide discusses, primarily from a microbiological aspect, the review and evaluation of high purity water systems that are used for the manufacture of drug products and drug substances. It also includes a review of the design of the various types of systems and some of the problems that have been associated with these systems. As with other guides, it is not all-inclusive, but provides background and guidance for the review and evaluation of high purity water systems. The Guide To Inspections of Microbiological Pharmaceutical Quality Control Laboratories (May, 1993) provides additional guidance. I. SYSTEM DESIGN High Purity Water System One of the basic considerations in the design of a system is the type of product that is to be manufactured. For parenteral products where there is a concern for pyrogens, it is expected that Water for Injection will be used. This applies to the formulation of products, as well as to the final washing of components and equipment used in their manufacture. Distillation and Reverse Osmosis (RO) filtration are the only acceptable methods listed in the USP for producing Water for Injection. However, in the bulk Pharmaceutical and Biotechnology industries and some foreign companies, Ultra Filtration (UF) is employed to minimize endotoxins in those drug substances that are administered parenterally. For some ophthalmic products, such as the ophthalmic irrigating solution, and some inhalation products, such as Sterile Water for Inhalation, where there are pyrogen specifications, it is expected that Water for Injection be used in their formulation. However, for most inhalation and ophthalmic products, purified water is used in their formulation. This also applies to topicals, cosmetics and oral products. VI. HEAT EXCHANGERS One principal component of the still is the heat exchanger. Because of the similar ionic quality of distilled and deionized water, conductivity meters cannot be used to monitor microbiological quality. Positive pressure such as in vapor compression or double tubesheet design should be employed to prevent possible feedwater to distillate contamination in a leaky heat exchanger. An FDA Inspectors Technical Guide with the subject of "Heat Exchangers to Avoid Contamination" discusses the design and potential problems associated with heat exchangers. The guide points out that there are two methods for preventing contamination by leakage. One is to provide gauges to constantly monitor pressure differentials to ensure that the higher pressure is always on the clean fluid side. The other is to utilize the double-tubesheet type of heat exchanger. High Purity Water System
  • China the Clean Room Application Industries:Food, beverage, aquatic products, frozen, baked Recommended level:10,000-300,000 I. There are many hidden dangers in food safety. In the face of excessive bacteria and other incidents in the food industry, it is necessary to carry out reform in high-standard food production enterprises. There will be no repeat of the low-invest, high-profit food industry of the past. Now should be high-standard invest, which will be recognized by consumers and make profits. II. Food Standard GMP Clean Workshop structure: the food processing purification workshop mainly adopts the steel mix or brick structure, and according to the needs of different products, the structure design is suitable for specific food processing special requirements. The space of workshop should suit with actual production requirement, in general situation, the production workers in GMP clean workshop should have independent area (besides equipment), and this area should not be less than 1.5 square metre. The overcrowded purification workshop not only hinders the production operation, and also causes product pollution easily due to the collision between personnel and the contact between personnel's work clothes and production equipment. The top height of the workshop shall not be less than 3 meters, and the cooking room shall not be less than 5 meters. The processing area and the health facilities of the processing personnel, such as the dressing room, the wind shower room, etc., should be the conjoined structure on the building. Storage and processing areas for baked goods, baked goods and frozen foods should also be incorporated. We have professional design team and installation team for providing complete solution for GMP workshop designing, construction and operation for different industries regarding Food & Beverage Products, Electronic Items, Photoelectricity Products, Medical Products, laboratory and Hospital Operating Room. We are professional solution provider for GMP Clean System projects, we can represent high quality and professional standard for China GMP clean room project and related equipment. We insist principle of "win-win business" and "exceed expectation" to serve our customers. We do most suitable customize design for each GMP clean workshop based on customer's actual requirement and different factory location and actual setting. China the Clean Room
  • The manufacture of High Purity Water System in China For purified water systems, microbiological specifications are not as clear. USP XXII specifications, that it complies with federal Environmental Protection Agency regulations for drinking water, are recognized as being minimal specifications. There have been attempts by some to establish meaningful microbiological specifications for purified water. The CFTA proposed a specification of not more than 500 organisms per ml. The USP XXII has an action guideline of not greater than 100 organisms per ml. Although microbiological specifications have been discussed, none (other than EPA standards) have been established. Agency policy is that any action limit over 100 CFU/mL for a purified water system is unacceptable. The purpose of establishing any action limit or level is to assure that the water system is under control. Any action limit established will depend upon the overall purified water system and further processing of the finished product and its use. For example, purified water used to manufacture drug products by cold processing should be free of objectionable organisms. We have defined "objectionable organisms" as any organisms that can cause infections when the drug product is used as directed or any organism capable of growth in the drug product. As pointed out in the Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories, the specific contaminant, rather than the number is generally more significant. High Purity Water System process
  • High Purity Water Systemsr basic reference used for the validation of high purity water systems is the Parenteral Drug Association Technical Report No. 4 titled, "Design Concepts for the Validation of a Water for Injection System." The introduction provides guidance and states that, "Validation often involves the use of an appropriate challenge. In this situation, it would be undesirable to introduce microorganisms into an on-line system; therefore, reliance is placed on periodic testing for microbiological quality and on the installation of monitoring equipment at specific checkpoints to ensure that the total system is operating properly and continuously fulfilling its intended function." In the review of a validation report, or in the validation of a high purity water system, there are several aspects that should be considered. Documentation should include a description of the system along with a print. The drawing needs to show all equipment in the system from the water feed to points of use. It should also show all sampling points and their designations. If a system has no print, it is usually considered an objectionable condition. The thinking is if there is no print, then how can the system be validated? How can a quality control manager or microbiologist know where to sample? In those facilities observed without updated prints, serious problems were identified in these systems. The print should be compared to the actual system annually to insure its accuracy, to detect unreported changes and confirm reported changes to the system.
  • One of the basic considerations in the design of a system is the type of product that is to be manufactured.Water For Injection Systems For parenteral products where there is a concern for pyrogens, it is expected that Water for Injection will be used. This applies to the formulation of products, as well as to the final washing of components and equipment used in their manufacture. Distillation and Reverse Osmosis (RO) filtration are the only acceptable methods listed in the USP for producing Water for Injection. However, in the bulk Pharmaceutical and Biotechnology industries and some foreign companies, Ultra Filtration (UF) is employed to minimize endotoxins in those drug substances that are administered parenterally. For some ophthalmic products, Water For Injection Systems such as the ophthalmic irrigating solution, and some inhalation products, such as Sterile Water for Inhalation, where there are pyrogen specifications, it is expected that Water for Injection be used in their formulation. However, for most inhalation and ophthalmic products, purified water is used in their formulation. This also applies to topicals, cosmetics and oral products. Another design consideration is the temperature of the system. It is recognized that hot (65 – 80℃) systems are self sanitizing. While the cost of other systems may be less expensive for a company, the cost of maintenance, testing and potential problems may be greater than the cost of energy saved. Differences between purified water systems and water for injection Whether a system is circulating or one-way is also an important design consideration. Obviously, water in constant motion is less liable to have high levels of contaminant. A one-way water system is basically a "dead-leg". Finally, and possibly the most important consideration, is the risk assessment or level of quality that is desired. It should be recognized that different products require different quality waters. Parenterals require very pure water with no endotoxins. Topical and oral products require less pure water and do not have a requirement for endotoxins. Even with topical and oral products there are factors that dictate different qualities for water. For example, preservatives in antacids are marginally effective, so more stringent microbial limits have to be set. The quality control department should assess each product manufactured with the water from their system and determine the microbial action limits based on the most microbial sensitive product. In lieu of stringent water action limits in the system the manufacturer can add a microbial reduction step in the manufacturing process for the sensitive drug product(s).
  • Water For Injection Systems egarding microbiological results, for Water For Injection, it is expected that they be essentially sterile. Since sampling frequently is performed in non-sterile areas and is not truly aseptic, occasional low level counts due to sampling errors may occur. Agency policy is that less than 10 CFU/100ml is an acceptable action limit. None of the limits for water are pass/fail limits. All limits are action limits. When action limits are exceeded the firm must investigate the cause of the problem, take action to correct the problem and assess the impact of the microbial contamination on products manufactured with the water and document the results of their investigation. With regard to sample size, 100 - 300 mL is preferred when sampling Water for Injection systems. Sample volumes less than 100 mL are unacceptable. The real concern in WFI is endotoxins. Because WFI can pass the LAL endotoxin test and still fail the above microbial action limit, it is important to monitor WFI systems for both endotoxins and microorganisms. Figures 3-5 represent a typical basic diagram of a WFI system. Most of the new systems now use multi-effect stills. In some of the facilities, there has been evidence of endotoxin contamination. In one system this occurred, due to malfunction of the feedwater valve and level control in the still which resulted in droplets of feedwater being carried over in the distillate.
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Ben LiuMr. Ben Liu

Mr. Ben Liu

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  • Tel:86-750-3094316
  • Mobile Phone:+8613725957662
  • Address:RM 1918, B Buliding, Wanda Plaza, Jiangmen City, Guangdong, China, Jiangmen, Guangdong
  • Country/Region:China
  • Website:https://www.lndcleanroom.com
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