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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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NEWS
  • 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.
  • Leonard Industrial 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, Food Industry GMP Clean Room 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, Food Industry GMP Clean Room Photoelectricity Products, Medical Products, laboratory and Hospital Operating Room.
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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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