Pre-filled sealing and filling equipment
operation and safety

LT-TSB Automatic denesting machine for prefilled syringes (3)

Higher production requirements for pre filled syringe filling and sealing

In recent years, China has developed pre-filled sealing and filling equipment that meets GMP requirements in the pharmaceutical industry. These syringe filling equipment can meet the production line needs of pharmaceutical factories, such as powder syringe filling, large infusion filling, ampoule washing, drying, and sealing.

 With the emergence of new pharmaceutical products, such as biopharmaceuticals, vaccines, gene drugs, and new anti-cancer drugs, the packaging forms and production line requirements are becoming higher. Therefore, the primary condition for equipment selection is to meet the requirements of syringe filling equipment production process technology. The contact parts of the equipment should be made of 316L stainless steel material, designed reasonably, and without dead corners to achieve online cleaning and sterilization. In addition, the syringe filling equipment should not contaminate the products and the environment during use, and should be easy to clean, disinfect or sterilize, in line with equipment validation requirements.

For drugs produced using aseptic processes, syringe filling equipment that comes into contact with inner packaging materials or drugs, such as aseptic liquid dispensing tanks, should consider designing online cleaning and sterilization functions. The components of the pre-filled sealing and filling machine should be easy to disassemble for offline cleaning and sterilization. In addition, pre-filled sealing and filling equipment should adopt highly automated facilities such as automatic bag tearing, paper tearing, and filling and capping to reduce human intervention, improve product quality stability, and reduce filling volume fluctuations. For the cleaning of dedicated components, dedicated cleaning equipment should be designed to ensure the reproducibility of the cleaning effect. During manual cleaning, detailed operating documents should be developed and the effectiveness evaluated, taking into account the impact of different operators on the cleaning effect.

In terms of operation and safety of pre-filled sealing and filling equipment, the first thing to consider is the requirements for personnel. Personnel are the biggest source of contamination, so a closed system should be used in high-contamination risk operations, such as restricted access barrier systems (RABS) and isolators, to effectively isolate personnel from products. In addition, in clean areas, the hygiene, quantity, dressing, and behavior of personnel need to be standardized and regulated. By gradually unpacking to reduce contamination in clean areas, pollution from personnel can be reduced. The number of personnel entering the aseptic production clean area should be kept to a minimum to reduce the generation of particles and microorganisms. Personnel need to undergo health checks before entering the clean area and maintain good health. At the same time, personnel training and qualification confirmation are also necessary. Only trained personnel who have passed clothing confirmation can enter the aseptic production clean area.

Equipment safety requirements are also very important. Pre-filled sealing and filling equipment is equipped with complex automated devices, where cylinders and servo motors are used as power sources, and components such as cams and linkages can easily cause personal injury. Therefore, correct operation of the machine and knowledge of safety instructions and regulations to prevent accidents must be mastered during equipment operation.

In terms of equipment installation, newly purchased equipment should undergo unpacking acceptance and check the match between equipment information and requirements. It is preferable for professional personnel who are familiar with the equipment to perform the installation, as they can reduce hidden dangers during the installation and commissioning process. The pre-filled sealing and filling equipment has a high degree of automation, so the suitability of the environment, such as temperature and vacuum, should be considered during the installation process.

In the operation of syringe filling equipment, corresponding parts should be replaced according to different product specifications, and it is necessary to ensure the correct replacement of the parts, otherwise equipment damage may occur. The operation steps of the filling equipment include starting the equipment, automatic resetting check, eliminating air bubbles in the liquid, filling, and capping.

Equipment maintenance and upkeep are also crucial for the normal operation of the equipment. Equipment failures may occur during operation, so it is necessary to understand the working principle of the equipment and common troubleshooting methods. At the same time, daily maintenance and upkeep of the equipment should not be ignored, including cleaning, inspection, lubrication, tightening, and adjustment, to maintain equipment performance and avoid deterioration.

In conclusion, the operation and safety of pre-filled sealing and filling equipment are crucial in the pharmaceutical industry. By selecting appropriate syringe filling equipment, standardizing personnel requirements, ensuring the suitability of equipment installation, following correct operating procedures, and conducting equipment maintenance and upkeep, the safe operation of pre-filled sealing and filling equipment can be ensured, product quality stability can be improved, and the packaging needs of new drugs can be met.

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