Parenteral drugs: flexible friends
Paolo Golfetto, Ompi discusses changing pharmaceutical operations for parenterals through a new flexible concept.
Today pharmaceutical companies face a high amount of costs for developing new parenteral drugs and there are many cases of patent losses. There is the need to offer them new manufacturing solutions as their target in this scenario is to lower cost pressure, increase flexibility and quality, reduce time to market and outsource non core activities.
Ompi aims to ease these problems providing a new filling platform based on a new flexible concept.
The manufacturing development process for new or existing drugs, especially for the emerging biotech needs or small batch needs, is often delayed due to the limited availability of filling options with an acceptable cost for the start up and formats of existing aseptic lines.
In a traditional pharmaceutical manufacturing process for parenterals, a pharmaceutical company deals with many phases, just for the proper preparation of the container system: washing, depyrogenation, sterilisation, filling, capping and crimping. This consolidated process allows them to benefit from a high speed and a high capacity but it also has some disadvantages – less flexibility, a larger footprint, high operating and validation costs and high glass-to-glass contact risk. Everybody knows that glass-to-glass contact is responsible for a series of problems that result in costs increase and risk of recalls: cosmetic issues, scratches, breakage and particle generation.
As not all the phases indicated are core activities for the pharmaceutical companies, Ompi EZ-fill solution aims to ease this pharmaceutical manufacturing process. By providing pharmaceutical companies with already washed and sterile containers (both in tray and in nest and tub format), this new flexible concept allows them to reduce space required for operations and to avoid the need of cleaning glass packaging before filling because it outsources non core activities. Moreover, it enables processes which reduce or eliminate glass –to-glass contact. This is assured through the nest and tub solution, thanks to a specific design of the packaging material that should preserve both particulate and cosmetic aspects. This reduces filling line downtime linked to broken containers and particle generation both in the transportation phase and in the buffering/in-feeding operations. The nest and tub format is provided for all sterile containers (vials, cartridges and syringes), so pharmaceutical companies can maximise flexibility in aseptic filling using a common filling platform (combi line). The Ompi EZ-fill is designed to be a flexible concept as it has been developed with the main fill and finish equipment manufacturers and can therefore be easily integrated into existing pharmaceutical manufacturing filling lines. Machine manufacturers have also been involved in the development of the packaging design and concept for the proper handling and machine-ability with a range of fill and finish units.
Ready-to -fill glass containers can be also packaged in tray format that can be processed in existing lines (adapted or revamped). This solution allows more containers for packaging unit and pharmaceutical companies can minimize manufacturing costs increasing efficiency.
The Ompi EZ-fill process has the following phases:
Incoming materials: containers are supplied to the Ompi EZ-Fill area (ISO7 and ISO5 under laminar flow).
Washing: containers are washed into the washing machine with WFI (Water For Injection).
Siliconisation: cartridges are siliconised with high performances layer distribution process (baked silicone).
Heating: drying and depyrogenation (only for vials and cartridges) in an oven. The cycle is optimised in order to reduce the timing and assure an optimal drying.
Packaging: the final steps place syringes, vials and cartridges into two final packaging solutions – tray: one piece box (only for vials) and nest and tub: nest and tub format (for all types of containers: syringes, vials, cartridges).
Both formats are sealed with a Tyvek lid, packaged in steribags and case-pack allowing for sterilisation. Key attention is given to the cleanliness of the packaging components as to the production of the glass container itself. Final configuration includes packaging in pallets.
Final sterilisation: filled tubs/tray in steribags are sterilised by EtO or steam (steam sterilisation upon request).
Capping: cartridges can optionally (upon customers’ request) be pre-capped.
The Ompi EZ-fill process is GMP compliant and already approved by numerous pharmaceutical companies.