Over the last few years, biopharmaceutical-processing platforms moved from rigid traditional stainless steel to flexible single-use technology.
The platforms created the ability to run the process more efficient and with higher agility. The need to evolve from fixed and rigid to flexible and agile systems did not stop with processes, but now shifted focus to facility designs.
Traditionally the facilities build, were product dedicated, large if not convoluted and involved lengthy time-to-run periods. New plug and play, lego format, facility designs are required to be able to create facility flexibility.
The paper will present such plug and play options, production process platforms, which can be employed fast track and with high degree of flexibility.
It will scrutinize the options and the feature and benefits of new modular designs, which can be assembled to entire processes or kept as unit operation. Example cases of such modular site designs will be presented.
The use of ready to use (RTU) primary packaging materials (PPM) in aseptic filling is gaining popularity among drug manufacturers.
To make the change from traditional PPM preparation to RTU on existing equipment can present challenges including process changes, equipment retro-fitting and new handling tools.
Vetter Development Services Chicago is a CDMO offering clinical cGMP aseptic filling for vials, syringes and cartridges and has recently executed this process change in order to use RTU vials on an already existing filling line.
This presentation will discuss the challenges encountered when developing the process and the solutions that were implemented to achieve success.
It will also describe the manual process steps followed to ensure sterility while introducing the RTU vials to the filling equipment. This RTU process has been in effect for just over a year and has been validated via multiple mediafills.
Companies are looking to decrease the time required to bring drugs into clinical trials and also to reduce the capital investment costs.
Building a new facility for filling requires a large amount of capital expenditure and also requires a lot of time. One way to effectively reduce the capital costs and to decrease the time to start up a new facility is through the use of disposables.
The installation of a flexible modular Isolator filling line reduces the capital cost by allowing for one Isolator to be installed for two separate filling lines with the capacity to supply clinical trials and commercial launch material demands.
The flexible modular Isolator filling line is designed to utilize ready to use components including filters, bags, syringes and vials.
The presentation will describe the layout of the flexible modular Isolator filling line and how it incorporates the use of ready to use vials.
The challenges placed on machine manufacturers serving the pharmaceutical industry are steadily increasing.
There are currently three main issues in focus:
1. Stopper handling: demand for lower oxygen content in stoppered containers, reduction in the gap between liquid and stopper, processing of coated stoppers and gentle stopper loading are becoming more frequent.
2. Automatic and high IPC rates are of prime importance.
3. Increased flexibility for handling of ready-to-use syringes, vials and cartridges on a single standardized machine. Machine manufacturers need to act on such challenges with sophisticated and flexible solutions. OPTIMA pharma will present various stoppering methods and engineering solutions integrated in a single multiuse filling machine.
Recent developments and future perspectives of particulate matter detection in lyophilized products
Lyophilization of parenteral drugs has gained application over the recent years. This preservation method extends the shelf life of products and prevents chemical interaction between aggressive product and glass.
With the increased demand for lyophilized products the interest for automated inspection of these products has gained more attention.
In this talk we will cover recent developments in detection of particulate matter. More specifically, we will focus on new methods for detection of glass chucks, because these fragments are typically challenging to differentiate from a glossy/shiny cake surface.
Finally, we will discuss the application of hyper spectral imaging to facilitate better separation between product and foreign materials.