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All publications for the rubric Validation

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Particle Measuring Systems releases the new Pharmaceutical Net® Pro Environmental Monitoring Software for FacilityPro® Environmental Monitoring Systems.

Pharmaceutical Cleanroom Monitoring Software Solution

Particle Measuring Systems® (PMS) introduces the new Pharmaceutical Net® Pro cleanroom monitoring software for data and collection management, reporting and automation built on an industrial automation architecture.  The software is used with FacilityPro® Processors which connect directly to env…
Pajunk GmbH develops and manufactures various medical technology products. At the headquarters in Geisingen, Baden-Württemberg, a new production and logistics center has been built, featuring a cleanroom of GMP Class D, covering an area of 1,015 m². (Source: bc-technology GmbH) Various work steps are carried out in the new cleanroom: These include, among others, the production of products for biopsies and anesthesia as well as testing and packaging processes. (Source: bc-technology GmbH) Various work steps are carried out in the new cleanroom: These include, among others, the production of products for biopsy and anesthesia as well as inspection and packaging processes. (Source: bc-technology GmbH) Some components are manufactured using the plastic injection molding process. However, production in the cleanroom has the disadvantage that the machines generate a lot of heat, which results in high energy consumption due to the installed air conditioning units. Therefore, bc-technology, in collaboration with the injection molding machine manufacturer, developed a concept that allows the machines to be integrated into the cleanroom wall without the development of unwanted particles. (Source: bc-technology GmbH) Some components are manufactured using the plastic injection molding process. However, production in the cleanroom has the disadvantage that the machines generate a lot of heat, which leads to high energy consumption by the installed air conditioning units. Therefore, bc-technology, together with the injection molding machine manufacturer, developed a concept that allows the machines to be integrated into the cleanroom wall without the development of unwanted particles. (Source: bc-technology GmbH) Some components are manufactured using the plastic injection molding process. However, production in the cleanroom has the disadvantage that the machines generate a lot of heat, which leads to high energy consumption due to the installed air conditioning units. Therefore, bc-technology, in collaboration with the injection molding machine manufacturer, developed a concept that allows the machines to be integrated into the cleanroom wall without the development of unwanted particles. (Source: bc-technology GmbH) The injection molding machine is located in the black area of the new production and logistics center. However, it can be loaded and unloaded from the cleanroom. For the injection area, a horizontally flowing filter fan unit (FFU) was attached to the housing of the injection molding machine as a protective zone, ensuring that the components are always kept under cleanroom conditions. (Source: bc-technology GmbH) The injection molding machine is located in the black area of the new production and logistics center. However, it can be loaded and unloaded from the cleanroom. For the molding area, a horizontally flowing filter fan unit (FFU) was attached to the housing of the injection molding machine as a protective zone to ensure that the components are always kept under cleanroom conditions. (Source: bc-technology GmbH) During the planning of the cleanroom, bc-technology had to consider Pajunk's requirement that machines can still be connected afterwards, which are to be put into operation at different times and independently of each other. (Source: bc-technology GmbH) In the visitor corridor area, the cleanroom features a full-height, large-area glass wall. (Source: bc-technology GmbH)
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Cleanroom solutions for the manufacturing of medical technology - sophisticated concept allows for the subsequent installation of additional machines

A clean affair: Integration of injection molding machines into the cleanroom wall reduces energy costs and prevents particle ingress

Since the 1960s, Pajunk GmbH has been developing and manufacturing various products for medical technology. To prevent contamination by germs and particles, production must take place in cleanrooms that meet the high standards of the EU-GMP guideline. However, the production of components for biopsy…
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The Italian Biochemical Institute, Comecer, and Particle Measuring Systems share expertise to develop and manufacture a safer intravenous solution.

Industry Experts Combine to Create Safer Intravenous Delivery

The Italian Biochemical Institute (IBI) "Lorenzini", Comecer, and Particle Measuring Systems (PMS) recently partnered to leverage and combine the expertise of each entity to design a new drug delivery system and a filling line to safely and effectively manufacture it. A Quality Risk Management (QRM…
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