Projects

Manufacturing of highly volatile solvents for the orthopaedic applications

EMCM was approached by a major medtech company with a request to fill custom made ampoules, filled with volatile solvents, in an aseptic environment. EMCM played a significant role in testing and implementing a production process which could meet the required specifications of the customer. The appreciation of successfully implementing the project lead to a new request of filling standard ampoules of the same product in an aseptic environment. EMCM assisted the customer with the project definition & implementation & the relevant process and method validations. EMCM demonstrated knowledge of aseptic manufacturing processes, ability to adapt to customer requirements & ability to demonstrate core knowledge of the manufacturing of volatile liquids to successfully implement and manage the project.

Production of high viscous suspensions for viscosupplementation

The client approached EMCM for a fill – and – finish requirement for highly viscous gels in a syringe for a promising application in Osteoarthritis treatments. The scope of the project included assistance in the development of the commercial scale manufacturing process, selection and validation of primary packaging and associated method and process qualifications. Since the gel is cross linked and viscous, the product is sensitive to terminal sterilisation. EMCM played a significant role in designing and implementing the sterilisation process of the product. EMCM’s expertise with viscous suspensions, knowledge of steam sterilisation & combined with its tailored servicing approach proved to be beneficial in successfully implementing the project.

Liquids and suspensions for orthopaedic applications

EMCM has implemented an FDA compliant ampoule filling manufacturing process. The project is a finish-fill project for a US based company. The to-be handled bulk is a volatile liquid. Due to EMCM's experience in the handling of volatile liquids, we have been able to adapt this into a safe process in our qualified production areas. To implement the manufacturing we have carried out a pilot batch and this is subsequently transferred into a GMP batch. The scope of the project also includes the validation of analytical test methods that are required for the release of the product.

Process Development at EMCM for a medical aesthetic

Our client increased the forecast of the product 2 fold on short notice. To successfully pull off the execution, EMCM played a significant role in designing, testing and implementing an upscaled production process which could cater to the increased demand primarily by targeting 3 areas: Increasing the yield /batch, reducing the risk of contamination & reducing manual operations. The production is executed in an aseptic environment, by incorporating a closed system (bulk production). The scope of the project also included supporting the processes development with the relevant regulatory and qualification documentation and filing changes in the product dossier. EMCM‘s knowledge of aseptic manufacturing processes, ability to quickly respond to change in demand, project management - from design, testing, implementation and approvals at notified body played a significant role in catering to the increased demand on short notice.

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