Value of “ready to fill” Packaging Materials: Concepts for Clinical or Commercial aseptic Production (Ingo Presser, Boehringer Ingelheim)
The presentation discusses the advantage and risks of using “ready to fill” concepts from the view point of a pharmaceutical contract manufacturing company.
What are the advantages, regarding invest, running costs, change over, space and process flow versus the risks of outsourcing the sterilization and cleaning of a substantial part of a product, the primary packaging material.
Ready to use syringes: pharma perspective (Jose Maria Vega, ROVI CONTRACT MANUFACTURING, S.L)
The number of new drugs approved are in decline stage. The costs associated with these new drugs are increased. The number of units to be produced for clinical trials are increasing due to the multiple analysis, and expected units for new drugs are lower due to the costs policies of the Governments.
In this scenario, the risks associated with operations to get these new drugs in injectable form must be minimized and companies must diversify looking for suppliers that are partners better than providers.
In this strategy, syringes in Ready to Use (RTU) format are a perfect solution to the drug's safety and cost savings both at Industrial Development and subsequent production stages.
Glass containers are the primary packaging choice for drugs and vaccines in the pharmaceuticals market due to the intrinsic inert nature of glass Type I.
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 new quality level based on 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.
QA on sterile production process (Boris Schmid, Stevanato Group)
This presentation explains the responsibility of the organization Assurance (QA) in the EZ-fill process for the manufacture of sterile products (RTF).
It is written, what are the main activities of quality control (QC) procedures for processes as "Attaching the needle", "Production EZ-fill" and "external Sterilization" as well as for input materials.
All this allows us to deliver a quality certificate guaranteeing a safe product along with representative samples.
Ready to fill Rubber Components (Ana Isabel Gutierrez Lopez, West Pharmaceutical)
Pharmaceutical companies are challenged to find consistent, reliable, high-quality packaging solutions that are manufactured with patient safety in mind.
The presentation will focus on elastomeric packaging components developed for demanding biopharmaceuticals and sensitive drug formulations.
Packaging options for elastomeric closures have been developed to support outsourcing strategies in the industry. As an example pharmaceutical companies can reach out to the primary packaging supplier for washing processes as well as sterilization treatments to receive “ready-to-use” components.
The 100% automated camera inspection of primary packaging components will be highlighted to answer the growing quality expectations in the market.
A new generation of machines with continuous handling at high speed increases the Optrel portfolio for the next years.
New high speed and high resolution sensor technology in conjunction with more powerful real-time dedicated processing electronics open opportunities to increase the performances of the inspection machines by implementing not only detection algorithm but also classification strategies in real-time.