Drug delivery systems enable the introduction of a therapeutic substance into the body. The systems integrate the route of administration and dosage to facilitate the efficacy and safety of the medicinal product. Drug delivery will control the rate, time, and place of release of drugs in the body. The utilisation of drug delivery systems is expanding because of the globally increasing burden of chronic disease, the development of treatments to address these and the requirements to deliver the interventions effectively.
Placing the patient at the centre of care has driven innovation of drug delivery systems. The drug delivery system innovation must be made available to users with evidence of proven efficacy & that design, manufacturing and supply ensure safe and effective use by the intended users in the use environment. Pharmaceutical companies and partners invest significant resources to generate such evidence.
To realise and maximise the benefits of the resource investment co-operation with an experienced strategic partner is often the best solution. Working with SteriPack enables product manufacture promptly while ensuring that the drug delivery system meets applicable requirements and specifications. SteriPack offers expertise in services dedicated to both pharmaceutical and medical devices industries. Our facilities handle all medical products according to stringent pharmaceutical regulations and good manufacturing practices, providing your company with the highest standards and safety for end-users.
SteriPack experience with pharmaceutical, combination and medical device products will be applied to ensure the processes & products are safe and effective. SteriPack follows verified and validated methods and procedures to design, & implement processes and products that meet requirements and have objective evidence demonstrating compliance with requirements.
SteriPack’s competences comprise combination product, drug delivery systems and procedure pack assembly. In-house clean room injection moulding or additive (3D printing) manufacturing processes manufacture components for assembly. A controlled supply management ensures that materials are purchased from qualified suppliers. Drug delivery device assembly is compliant with ISO and cGMP regulations and takes place in dedicated Grade D clean room.
SteriPack Group shares its expertise and ideas for the optimisation of the assembly process, ensuring that all essential process controls are combined with the most competitive solution. Depending on the Customer’s requirements and the product lifecycle, the answers vary from manual to semi-automatic or automated assembly processes enabling development and or clinical scale through to market. SteriPack group designs develops and validates processes to reliably and reproducibly ensure compliance with product specifications.
All assembly processes are ISO 13485 and FDA requirements compatible. We follow current good manufacturing practice for pharmaceutical and medical device.
Drug delivery and combination products services at SteriPack include, but are not limited to:
- Regulatory support
- cGMP | ISO 7 and 8 clean room packaging
- Cold chain storage
- Design and development (design review, robust design, DFM, DFA)
- 3D Printing and additive manufacturing
- Injection molding
- Assembly and kitting
- Sterile barrier packaging
- Sourcing of packaging components
- Serialization and aggregation (up to level 3)
- Process validation