Biodegradable Implants
IMSTec has developed a fully automated production line for applicators in ophthalmology. These inject an implant that degrades over a certain period of time.
Small implant with a big effect
What is a drug implant? The drug implant consists of a polymer compound and is mixed with the active pharmaceutical ingredient. It is injected into the body in the form of a small rod just a few millimeters in size. The implant, which is sometimes only a few millimetres in size, is injected under the skin and remains there for a certain period of time.
How does it work? Depending on the application, the active ingredients are released continuously over several months and are biodegradable, i.e. the implants dissolve completely in the patient's body. This single, targeted application ensures the optimum supply of active ingredients. This application is particularly beneficial for patients who are unable to take their medication regularly. Drug implants are a promising innovation in medicine. With their diverse fields of application and positive effects on drug adherence, they could revolutionize the future of drug therapy.
Where are the implants used? The range of applications covers various medical areas and is constantly being further developed. The innovative drug implants are already being used in ophthalmology, hormone therapy, addictive disorders and even cancer therapy.
The decisive factor for all medical disciplines is the long-lasting effect for the patient. Particularly when drug adherence cannot be guaranteed, the implant under the skin represents a safe alternative to conventional oral medication. Due to the gradual degradation in the body, an optimal dosage can be achieved.
In summary, this means more comfort and safety for chronically ill patients and less monitoring and follow-up treatment for the treating physicians.
Development of an automated production line
We developed and built the entire production line for a single-use applicator in ophthalmology for our customer. From the extrusion process of the drug-polymer mixture, to the cutting of the filament, the finishing of the cannulas, the assembly of the applicator and the packaging - the entire manufacturing process was automated. Automated quality control (inline control) is integrated into the production process and inspects all components.
Requirements during development:
High degree of automation | Large-scale production
Consistent product quality
Economical production parameters
Challenges:
- Sterile and safe processes: From the extrusion of the implant, the aseptic assembly of the applicator to the primary packaging in pouches - the product must pass the highest quality standards and must not have any defective properties.
- Size and properties of the product: Some of the components have a diameter of less than 0.5 mm. The needles must also be extremely sharp so that they can be inserted into the eye.
- Regulatory framework: GMP conditions for the manufacturing process, in particular the requirements of Annex 1, are becoming increasingly stringent:
Due to the introduction of a comprehensive contamination control strategy (CCS) in the revised version of 2022, this means that exposed implants must mandatorily be processed in an ISO Class 5 (Class A) environment. This has an impact on system designs and production processes. - Single-part traceability: All components and process parameters must be traceable.
Overview of the process
Extrusion of the drug-polymer mixture
Extrusion of the drug-polymer mixture
Production of the drug implant in long strands
Cutting of the implant strands
Cutting of the implant strands
Precise cutting and measuring of the individual implants
Weighing the cut implants
Weighing the cut implants
Using precision weighing systems
Surface treatment and needle assembly
Surface treatment and needle assembly
Siliconization processes enable a sharpened surface
Assembling the applicator and final inspection
Assembling the applicator and final inspection
Needle and applicator with protective cap are joined together
Labeling and packaging process
Labeling and packaging process
Labeling and primary packaging
Project approach:
As part of a pFMEA (Process Failure Mode and Effects Analysis), we identify possible weak points and potential errors within production. Our technical documentation and quality management are consulted as early as the design development and system conception stages. The measures specified in the previously defined pFMEA are reviewed at every stage. This means that we can not only hand over a finished system to the customer, but also complete documentation for the successful validation of production.
The result:
- Automated quality control
- Production output of several million needles per year
- Traceability of all components and process parameters
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