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SYFPAC SECUREJECT - Prefilled Syringe Manufacturing System
The SYFPAC SECUREJECT system is employed for the production of prefilled syringes and injection devices using Blow-Fill-Seal (BFS) technology. Ideal for mass production, it can produce syringes ranging from 0.5ml to 20ml sizes swiftly, forming, filling, and sealing each unit under aseptic conditions in just 16 seconds. The versatile machinery handles different polymers such as PP, PE, and HDPE, and does not require mold changes, thus optimizing operational efficiency. Its compact design needs minimal cleanroom space, requiring only a Class C environment for operation. The machine's production rate reaches up to 5,100 units per hour, and it can run continuously to meet demanding production schedules. Moreover, it can safely handle temperature-sensitive formulations, making it suitable for a variety of applications including vaccines, injectables, and biologicals. The system integrates a user-friendly HMI and adheres to CFR 21 requirements, ensuring data integrity and a reliable operation that minimizes risks and costs.
SYFPAC® SECUREJECT® is designed for the manufacturing of Prefilled Syringes (PFS) and injection devices using BFS technology. It is the perfect choice for high production of plastic syringes from 0.5ml to 20ml. Starting from the polymer granule, the syringe is formed, filled and sealed inside one machine in only 16 seconds, under aseptic conditions.
APPLICATIONS
Vaccines, injectables, biologicals
VOLUMES AND MOULDS
From 0.5ml to 20ml
CLEAN ROOM
6.5 x 12 x 3.9 m
PRODUCTION RATE
Up to 5.100 units per hour
HIGH FLEXIBILITY
PE, PP, HDPE
SOLUTION PROPERTIES
From 4°C to 30°C
VOLUMES AND MOULDS
On SYFPAC® SECUREJECT® machine there are several designs available: from squeezable single dose syringe (with or without inserts) to a more standard design including piston and one or two inserts. Volumes can range from 0.5ml up to 20ml and the needle can be inserted or added later to a luer connector.
CLEAN ROOM
The compact size of the machine allows for reduced clean room dimensions of only 60 sqm, where only class C is required. Syringes are produced under grade A inside one machine only, with no need of additional steps that involve a larger clean room.
PRODUCTION RATE
SYFPAC® SECUREJECT® machine can produce up to 5.100 syringes per hour, as the syringes can be made, filled and sealed within 16 seconds per cycle. Suitable for mass production, the machine can work 24/7. Its robust construction, together with its smart preventive maintenance program, prevents failures and unexpected expensive maintenance.
HIGH FLEXIBILITY
Different types of polymers can be used on the same machine (PP, PE, HDPE), with no need to change the mould nor requiring complicated operations. By reducing the production steps and the cost of secondary packaging, the cost of prefilled syringes is significantly lower than normal syringe manufacturing.
SOLUTION PROPERTIES
SYFPAC® SECUREJECT® can safely fill temperature sensitive formulations like biologicals and vaccines, with some basic modifications to keep temperature solution below the requested range. Apart from solutions with viscosity similar to water, pastes and creams can also be filled.