Eduard Marty of Codols explains that pharmaceutical and lab cleaning equipment has special design features that manufacturers need to be aware of to ensure compliance.
        Equipment manufacturers follow strict standards when designing and manufacturing cleaning machines for the pharmaceutical industry. This design is important because various features are provided to comply with Good Manufacturing Practice (GMP equipment) and Good Laboratory Practice (GLP equipment).
        As part of quality assurance, GMP requires ensuring that products are produced in a uniform and controlled manner to quality standards appropriate to the intended use of the product and under the conditions necessary for trade. The manufacturer must control all factors that may affect the final quality of the medicinal product, with the main goal of reducing risk in the manufacture of the entire medicinal product.
        GMP rules are mandatory for all pharmaceutical manufacturers. For GMP devices, the process has additional specific goals:
        There are different types of cleaning processes: manual, in-place (CIP) and special equipment. This article compares handwashing to cleaning with GMP equipment.
       While hand washing has the advantage of versatility, there are many inconveniences such as long wash times, high maintenance costs, and difficulty in re-testing.
        The GMP washing machine requires an initial investment, but the advantage of the equipment is that it is easy to test and is a reproducible and qualified process for any tool, package and component. These features allow you to optimize cleaning, saving time and money.
        Automatic cleaning systems are used in research and pharmaceutical manufacturing plants to clean a large number of items. Washing machines use water, detergent and mechanical action to clean surfaces from laboratory waste and industrial parts.
        With a wide variety of washing machines for different applications on the market, several questions arise: What is a GMP washing machine? When do I need manual cleaning and when do I need GMP washing? What is the difference between GMP and GLP gaskets?
        Title 21, Parts 211 and 212 of the Code of Federal Regulations (CFR) of the US Food and Drug Administration define the regulatory framework applicable to GMP compliance for drugs. Section D of Part 211 includes five sections on equipment and machinery, including gaskets.
        21 CFR Part 11 should also be considered as it relates to the use of electronic technologies. It is divided into two main parts: electronic registration and electronic signature.
       FDA regulations for the design and manufacture of devices must also comply with the following guidelines:
        The differences between GMP and GLP washing machines can be divided into several aspects, but the most important are their mechanical design, documentation, as well as software, automation and process control. see table.
        For proper use, GMP washers must be correctly specified, avoiding higher requirements or those that do not meet regulatory standards. Therefore, it is important to provide an appropriate User Requirement Specification (URS) for each project.
        Specifications should describe the standards to be met, the mechanical design, process controls, software and control systems, and required documentation. GMP guidelines require companies to conduct a risk assessment to help identify suitable washing machines that meet the requirements already specified.
        GMP Gaskets: All clamp fitting parts are FDA approved and all piping is AISI 316L and can be drained. Provide complete instrument wiring diagram and structure according to GAMP5. The internal trolleys or racks of the GMP washer are designed for all types of process components, i.e. utensils, tanks, containers, bottling line components, glass, etc.
        GPL Gaskets: Manufactured from a combination of partially approved standard components, rigid and flexible pipe, threads and various types of gaskets. Not all pipes are drainable and their design is not GAMP 5 compliant. The GLP washer inner trolley is designed for all types of laboratory materials.
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