Pre-filled Syringes - A Review by Quality Management
Prefilled syringes, is fast catching on as a convenient, cost effective method of drug delivery in the world. Although the PFS has been around for almost 2 decades, the diversification of the use of PFS for conventional drugs from use in ‘niche drugs’ (such as genetic drugs, vaccines and anti-coagualants) is the latest facet being explored continually.
Having overcome the major hurdle of the compatibility and the stability issues, manufacturers need to focus on the challenges faced by them during the manufacturing and Quality control.
The use of container closure systems for self-injection devices
From a customer/patient point of view, the quality and safety of a drug product is often linked very close to the quality and appearance of the container closure system. Drugs administered with self-injection devices by non-professionals are encumbered with a much higher risk profile than drugs administered by professionals.
This is due to the facts that the common, non-professional user may not have the same practice of use, nor the same competence or awareness to assess whether the closure integrity of the container closure system or the function of the self-injection device may be impaired prior to use.
In order to mitigate the increased risk and meet the high expectations and derived quality requirements to the primary packaging materials, the pharmaceutical industry must apply a total quality view on primary packaging.
What are the regulatory requirements to primary packaging and how is an appropriate quality level achieved in practice.
Prefillable sterile glass containers for injectable: new choices and solutions for the market
Glass containers are the primary packaging choice for drugs and vaccines in the pharmaceuticals market due to the intrinsic inert nature of glass, referring in particular to Type 1 borosilicate glass with respect to Type III soda-lime.
Essential requirements of the new biotech formulations are high hydrolytic resistance, high neutrality and chemical resistance of the inner surface to preserve drugs potential, increase shelf life and reduce rejection rate for leachable.
The “ready to fill” concept is gaining market shares not only for syringes but also for cartridges and vials and asserts the need of a highly controlled dimensional accuracy for automating processes and the highest cosmetic level to reduce more expensive end-of-line rejection rate and assuring market acceptability.
PFS Rubber components: Meeting the increasingly strict standards set
Helvoet Pharma designs, produces and markets primary packaging components for pharma, diagnostic and medical devices striving to meet and even anticipate the ever increasing quality requirments of the Healthacare market especially in the PFS product range.
After a brief summary of our standard solutions to supply the market with state of the art components in the various market segments served with highlliting our novel Omniflex3G total coated closures we focus on our existing products range for the PFS which has been recently completed with product designs and rubber formulation compatible with the most sophisitcated drugs and solvents. OCP coated plungers are desrcirbed as well as rigid needle shields.
Packaging in dedicated containers equipped with RTP ports is presented both in steam sterilizable and irradiation resistant bags.
This presentation gives you an insight into the world of self-injection devices, the benefits of a device for the patients and your company.
In the presentation the different considerations to be made to choose the right device are highlighted. Not every patient group has the same needs and not every device is suitable for your specific drug/primary container combination.
This presentation deals with Sterile Filling and Closing under cGMP aspects.
In particular Mr Hans Thomas will talk about machine design according the current cGMP guideline concerning parenteral products carrying out the FDA requirements and the safety regulations valid in the EU and he will touch reliable solutions able to handle almost every kind of pharmaceutical container available on the market, from semi-automatic to fully automatic systems, for every output required by the customer.
In relation with these topics Mr Thomas will speak about the complete production of Bausch + Stroebel comprises the individual steps: washing, sterilizing, depyrogenation, filling, closing, conveying, buffering and loading in trays. Besides he will speak about production on line and stand-alone machines. He will also touch Qualification performance (IQ/OQ) of Bausch + Stroebel.