Patients receiving injectable treatments for chronic diseases, allergies and a number of other therapies critical to health have benefitted from patient convenient dosage forms. The use of pre-filled syringes, auto-injectors and pen injectors has enabled safe and effective self-injection. The devices are simple to use and precise, performing reliably and reproducibly.
Pre-filled syringe processing must assemble syringe components ensuring sterility / maintenance of sterility and ensuring maintenance of syringe performance within the set parameters.. This means the process development starting from design to manufacturing is very demanding. Every element must be accurately placed, assembled and packaged. From manual to fully automated processes SteriPack offers top quality resources required to set up effective production lines.
Our ISO 13485 and cGMP compliant facilities are supported by experienced and knowledgeable personnel along with the cutting-edge machinery necessary to provide the highest quality assembly solutions from conception to finished market goods. Our capacity is expanding and we are always prepared to set up efficient, cost-effective assembly lines for our customers. SteriPack performs end-to-end testing to ensure specifications are met, high performance and much more. We share expertise and ideas from small to large-scale production to increase optimization of the assembly process and find the most competitive solutions.
With every project we consider number of product presentations, annual batch size and device complexity. All processes take place in cGMP compliant clean room. Assembly solutions are developed from conception to finished market goods, our proven track record of setting up customized assembly lines covers manual, semi-automated and automated production. For new products with uncertain forecasts, SteriPack offers an individual approach for ramping up volumes. We manage a large variety of SKUs within specific product groups as well as small batch handling and we can also support customers with batches for clinical trials.
We take a proactive approach to provide the necessary space and equipment, expanding our SteriPack facilities every time we reach 75% capacity to ensure we are always prepared to set up efficient, cost-effective assembly lines and perform end-to-end testing to guarantee that all specifications are met. Our philosophy has always been to share ideas and expertise as well as to listen carefully to understand our customers and move forward with a common goal – to optimize the assembly process and find the most competitive solutions.
Every RFQ and project for PFS assembly and packaging is evaluated individually. We consider key factors such as device complexity, number of product presentations, annual demand and batch sizes. Control plans, IPC and release testing can be offered from SteriPack’s standard operating procedures or adjusted to meet specific customer requirements. OEM components and packaging materials can also be sourced by SteriPack through a network of approved local suppliers. All processes take place in clean room (for assembly and blistering) and dedicated packaging areas for tertiary packaging.
Our assembly services:
- Syringe labeling
- PFS with plunger rod / finger flange assembly (with IPC control)
- Syringe with safety device assembly (with IPC control)
- Kit packaging
- Functional testing
Our packaging solutions:
Our operational excellence program:
- Modular approach to manufacturing
- Full risk management system
- In-process controls (including automated camera system, mechanical control and go/no-go gauge)
- Electronic batch release (MES)
- Verification and validation throughout lifecycle
- Documented employee training
- Complete batch documentation
- Temperature control / recording according specifications
- Dedication to the principles of lean manufacturing
- 100% of Operators white belt trained