SYFPAC® SECUREJECT®

Applications:

• Vaccination Delivery
• Injectable Medications
• Biological Substance Administration

Main Features:

1. Volumes and Moulds:

   • The SYFPAC® SECUREJECT® apparatus offers a variety of designs, ranging from a squeezable single-dose syringe (with optional inserts) to a more conventional design that includes a piston and one or two inserts.
   • The volume capacities span from 0.5 ml to 20 ml, and the needle can either be inserted or later attached to a luer connector.

2. Clean Room Specifications:

   • The machine’s compact design necessitates only a 60 sqm clean room, with a class C requirement.
   • Syringes are manufactured under grade A conditions within a single machine, eliminating the need for additional steps and larger clean room spaces.

3. Production Rate:

   • The SYFPAC® SECUREJECT® machine boasts a production rate of up to 5,100 syringes per hour, with each syringe being manufactured, filled, and sealed in a 16-second cycle.
   • Designed for mass production, it operates 24/7 and its sturdy build, coupled with a smart preventive maintenance program, mitigates breakdowns and unforeseen costly maintenance.

4. High Flexibility:

   • The machine accommodates various polymer types (PP, PE, HDPE) without necessitating mould changes or complex operations.
   • By minimizing production steps and secondary packaging costs, the cost of producing prefilled syringes is notably lower than traditional syringe manufacturing.

5. Solution Properties:

   • SYFPAC® SECUREJECT® can securely fill formulations sensitive to temperature, such as biologicals and vaccines, with minor modifications to maintain the solution temperature below the specified range.
   • It can fill not only solutions with water-like viscosity but also pastes and creams.

Additional Features:

• Prefilled Syringes: Brevetti Angela has over 20 years of experience in producing prefilled syringes using BFS technology, continuously innovating and currently producing the fifth generation of prefilled syringes.

• Cost-Effective Production: The production cost of a pre-filled syringe using BFS technology ranges from 8 to 12 cents per unit, presenting the lowest manufacturing cost compared to glass or pre-moulded polymer containers.

• Risk Mitigation: The premeasured dosage minimizes the risk of dosage errors and reduces drug wastage. Additionally, prefilled syringes prevent reuse, thereby eliminating the associated risks of cross-infection or contamination.

• Ready for Use: Prefilled syringes are ready to use and are easily managed by healthcare professionals and patients alike.

• User-Friendly HMI: The machine’s Human-Machine Interface (HMI) is intuitively designed while adhering to CFR 21 requirements for data integrity. It automatically tracks necessary maintenance based on work hours and cycles, notifying the operator via the HMI.

• CIP & SIP: The machine automatically performs Cleaning In Place, Sterilization In Place, drying, and integrity testing.