Föreläsare tema renrum
Javier has been working in the pharmaceutical industry for more than 20 years. First part of this period he has been focused on the design and construction of clean rooms and critical utilities, from the design, construction until final qualification, point of view. The last 10 years has been mostly working in the machinery business for aseptic and containment processing. Specially working on full solutions for fill & finish and lyophilization of sterile medicines, and low temperature disinfection technologies for GMP applications.
Is co-founder of Litek Pharma, a company focused on the manufacturing of isolators and barrier systems for different applications in the aseptic processing for pharmaceutical and biotech industry, and main advisor for contamination control strategy.
Read more about Javier’s presentation below
The challenge of Fill and Finish of small batch of sterile medicines under new annex 1 of GMP
This presentation is focus on the fill and finish of small batches of sterile medicines in the pharmaceutical industry. The manufacturing of small batches is present in different kind of products manufacturing, like personalize vaccines, allergy vaccines, advanced therapies,…, and the adaptation to the new annex 1 of the GMP is not always easy.
The solution of the isolator normally is the best way, but sometimes we can find intermediate solutions, to allow a smoother transition from the current situation to the new regulatory scenario.
The presentation will cover:
- Main regulatory requirement to face.
- Fill & finish of small batches, freeze drying, and advanced therapies manufacturing current practices.
- Engineering and construction of customized barrier technologies.
- Solutions of high automated systems for small batches manufacturing.