Stick pack packaging machine & GMP requirements
The demand for pharmaceutical equipment is extensive, but the requirements are extremely strict. They need to complete production tasks efficiently and accurately, and must comply with international standards such as GMP to ensure the purity and stability of drugs. Intelligence and automation are also important features of modern pharmaceutical equipment to meet the urgent needs of the pharmaceutical industry for high-quality and efficient production.GMP requirements for stick pack packaging machine:
1. The design, selection and installation of equipment should meet production requirements; easy to clean, disinfect and sterilize, convenient for production operation and maintenance; maintenance, and can prevent errors or reduce pollution.
2. The part of equipment in direct contact with pharmacy products should be smooth, flat, easy to clean or disinfect, corrosion-resistant, and not chemically change with drugs or adsorb drugs. The transmission parts of the equipment should be well sealed to prevent leakage of lubricating oil, coolant, etc. from contaminating raw materials, semi-finished products, finished products and packaging materials.
3. The preparation, storage and distribution of purified water and water for injection should prevent the growth and contamination of microorganisms. The materials used for storage tanks and delivery pipelines should be non-toxic and corrosion-resistant. The design and installation of pipelines should avoid dead corners and blind pipes. Storage tanks and pipelines require specified cleaning and sterilization cycles.
4. The operation of equipment installation, repair and maintenance shall not affect the quality of the product.
5. For equipment with large dust generation in production, such as crushing, screening, mixing, granulation, drying, coating and other equipment, it is advisable to locally design dust collection, powder suction devices and dust-proof curtains.
6. In the production of sterile drugs, equipment, containers, pipelines, valves, delivery pumps, etc. that come into contact with the drug solution should be made of high-quality corrosion-resistant materials. The installation of pipelines should minimize the number of joints (welding) and filter equipment should not adsorb drug solution components and release foreign matter. It is prohibited to use filter equipment containing asbestos.
7. Purification devices should be installed for drying air, compressed air, inert gas, etc. that are in direct contact with drugs. After purification, the particles and microorganisms contained in the gas should meet the specified air cleanliness requirements. The air outlet of the drying equipment should be equipped with a device to prevent air backflow.
8. In addition to meeting the above requirements, the equipment in the sterile clean room should also meet the needs of sterilization.
GMP (Good Manufacturing Practice) has strict requirements for materials materials of packaging machines:
Packaging machines must use materials that meet the standards for pharmaceutical packaging materials, adapt to changes in packaging specifications, operate stably and be easy to clean. Its control device should have the functions of working status display, parameter setting modification and fault alarm. In addition, the packaging machine should also have safety protection measures to ensure that the batch number is printed clearly and does not pollute the drugs and the environment.
News from stick pack packaging machine manufacturer www.LiptonPack.com drip coffee bag packing machine factory.
