GMP Requirements Of Pharmaceutical Equipment

Suzhou Pharma has always provided the pharmaceutical industry with high standards and strict requirements for pharmaceutical clean rooms, laboratories, and pharmaceutical workshops. At the same time, we also solve pharmaceutical equipment problems for our customers. Pharmaceutical equipment usually comes into direct contact with drugs, so whether it is material, stability, quality, or production efficiency, they must meet the requirements of GMP.

The material of the equipment is safe, stable, heat-resistant, and corrosion-resistant. Completely enclosed during production, it will not cause pollution to the outside environment, nor will it be contaminated by the outside environment. The equipment should be easy to clean and preferably have a self-cleaning function. Pharmaceutical equipment has an automatic control system that can systematically control, count, and reduce labor costs. Some drugs have special properties, so it is best for pharmaceutical equipment to have dust-proof, waterproof, and explosion-proof functions. For safety reasons, there should be a one click pause automatic protection equipment.

In order to meet the various requirements of GMP, control is implemented during the customized production process of equipment. The appearance design should be as concise and clear as possible, reducing blind spots in work and minimizing the difficulty of cleaning caused by useless designs. During the entire process of equipment operation, pay attention to the rationality of the structure. The entry, extraction, transfer, processing, and output of materials should have a reasonable process, with no duplication of production lines, minimizing manual intervention, and preventing the introduction of bacteria and pollutants. The internal structure should reduce the use of squares and try to use polished circles and slopes as much as possible, which is beneficial for the transfer of internal items and avoids obstacles. Ensure the sealing of the machine and isolate the working or manufacturing area from the outside environment. Isolation covers can be set up. In the selection of materials. The characteristics of the drug should be considered to prevent chemical reactions that may affect the drug. The material in direct contact with the material is usually higher grade than the external material, usually 304 stainless steel or 316 stainless steel. Corrosion resistance, high and low temperature resistance should also be considered, and sometimes titanium alloys are also used.

Common pharmaceutical equipment includes dryer, grinder, vibrating screen, slicer, tablet press machine, soft capsule production equipment, capsule filling machine, blister packaging machine, granule powder packaging machine, mixer, falling film evaporator, supercritical CO2 extraction machine, centrifuge,etc.