Equipment manufacturers follow strict standards to design and fabricate washing machines for the pharmaceutical industry. Such design is important because provides different characteristics to comply with Good Manufacturing Practice (GMP equipment) and Good Laboratory Practice (GLP equipment). Included as part of quality assurance, GMP requirements ensure that products are manufactured in a uniform and controlled manner, in accordance with the quality standards appropriate to the intended use of the products and in accordance with the conditions necessary for trading. Manufacturers should control all the factors that may affect the final quality of the medicinal product with the main objective of reducing the risks concerning all pharmaceutical production. The GMP regulation is mandatory for all pharmaceutical manufacturers. There are different types of washing processes: manual, clean-in-place (CIP), and purpose-built equipment. This article provides a comparison between handwashing and washing with GMP equipment. While handwashing has the advantage of versatility, manual washing bears the inconvenience of long periods of time, high running costs, and difficulty in repeating and validating.

A GMP washer takes an initial investment, but the equipment boasts the advantage of a straightforward validation, it is a repeatable and qualified process, and suitable for any tool, packaging and component. These characteristics lead to washing that is optimised and time- and cost-efficient. Automatic washing systems are used in research and pharmaceutical production facilities to wash a large number of items. The washers use water, cleansing agents and mechanical action to wash laboratory waste and production components surface. A wide range of washers are available on the market for different applications, and such availability raises several questions: what is a GMP washer? When do I need of a manual washing and when a GMP washer is required? What are the differences between a GMP and GLP washers? The regulatory framework that applies to GMP compliance for pharmaceuticals is defined in the Code of Federal Regulations (CFR) Title 21, daily dietary supplement Parts 211 and 212 of the US FDA.

Paragraph D in part 211 includes five sections concerning equipment and machinery, including washers. Document 21 CFR part 11 should also be considered, as it deals with the use of electronic technology. It is divided into two main sections: electronic registers and electronic signatures. The differences between GMP and GLP washers can be classified into different aspects, but their mechanical design, documentation, and software, automation and process control are the most important. A GMP washer must be appropriately specified for its proper use, avoiding higher requirements or those that don't meet the regulatory criteria. Thus, it is important to provide the appropriate User Requirement Specification (URS) for each project. The specifications must state the standard to comply, the mechanical design, process control, software and control system, and the required documentation. The GMP guidelines require companies to carry a risk assessment that will help to determine the appropriate washer to satisfies that requirements already laid down. GMP Washers: all joints components are FDA approved with clamp connections, and all the pipes are AISI 316L steel and drainable. Complete instrumentation with connection diagram and construction according to GAMP5. Internal carts or racks of the GMP washers are specially designed for all types of process components, namely utensils, tanks, containers, components of filling lines, glass, and so forth. GPL washers: built with standard components partially approved, and a combination of rigid and flexible pipes, threads, and a combination of different types of gaskets.

Science continues to prove that the old adage "you are what you eat" is profoundly true. This is because you have trillions of microorganisms living in your gut, which are directly responsible for nearly every aspect of your health. These microbes make up what’s called your "gut microbiota." They are especially influential in determining your likelihood of gaining excessive weight, becoming obese, and developing obesity-related diseases like diabetes, heart disease, and premature death. The gut microbiome (the expressed genes of your gut microbiota) plays a major role in your metabolism through energy production, storage, and expenditure. So, it’s no surprise that science has found a strong connection between gut microbiome imbalance and metabolic syndrome. Yikes! If you have the wrong mix of microbes, it could be making it tough for you to get your health on track! Did you know: Scientists can actually look at your gut microbiome composition and tell with 90% accuracy if you are obese or lean. That’s pretty impressive, isn’t it?

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