This presentation will cover audit observations with respect to sterile manufacturing facilities to bring clarity to the regulatory requirements.
We will discuss in details current audit observation and 483’s in sterile manufacturing facilities. It will also focus on essential elements of Environmental Monitoring Programme to ensure purity, safety, and efficacy of the sterile products manufactured.
We will learn that Environmental surveillance is a tool utilized to evaluate the effect of controls on the manufacturing environment. It is a process to assess the clean room and other controlled environments of a pharmaceutical facility and can serve as an adjunct to the sterility assurance program for the microbial quality of drugs.
This presentation will give insight to the requirement and importance of microbial identification in sterile manufacturing facility. We will discuss that how characterization of microorganisms recovered from environmental and personnel monitoring is an important part of surveillance programs.
Biotech Products in Syringes ‐ Case Study: Product Transfer from a Vial into a dual‐chamber Syringe (Michael Vetter)
Vetter Pharma - Information Major differences between dual-chamber systems and vials Motivation to select a dual-chamber systems Correlation between middle stopper and residual moisture of the freeze-dried cake Approach for a “typical” product life-cycle development from vial to dual-chamber system.
The presentation covers the latest news and trends regarding the maturing market for reliable and easy to use pens and autoinjectors. It also reviews big and emerging pharma's strategies for the development and manufacture of pen and autoinjector systems.
Making Options Easy: EZ‐fill Vials, Cartridges and Syringes on a standard Nest&tub concept (Nicola Del Giudice)
The pharmaceutical market is moving towards complex and specialized drugs where the aim is more effective treatments targeting specific diseases.
This new scenario requires a high degree of flexibility to shorten development cycles and time to market, still providing superior quality containers to safely store these high potential drugs.
The growing trend is to choose combined packaging and devices including a set of key features that simplify all the operations in order to allow the Pharmaceutical Companies to focus on drug developments.
This paper presents an integrated solution to meet the market requirements focusing on a new process and packaging concept that change the paradigm of cost and technical approach.
Technical and Quality Considerations for Prefilled Syringe Elastomer Closures (Damien Saleur)
Evolution in the drug industry and the potential microbiological and particulate contamination of drug product require the establishment of ever stricter quality specifications to meet the latest demands of pharmaceutical laboratories.
The talk will illustrate technical and quality principles implemented in the production process of elastomeric closures ready to be used in a subsequent pharmaceutical manufacturing unit operation at the pharmaceutical manufacturer.
It will highlight benefits and limitations of such an approach as well as discuss responsibilities of the closure manufacturer and the user, respectively.
Turning Prefilled upside down: True passive Safety Devices that combine chemical Compatibility, user Friendliness, and cost effective assembly (Peter Forceville)
Today, the need for innovative solutions to deliver injectable products is at an all-time high.
With the growth of the prefilled syringe, the strict requirements on needlestick safety, and the ever increasing demand for patient safety and medication error reduction, drug delivery device development has many stakeholders.
From the standard Type 1 glass drug vial to the most cutting edge auto and patch injectors of today, device development has attempted to satisfy the stakeholders and increase safety and ease of use during drug administration.
MedPro’s technology meets the needs of primary packaging specialists with those of device development engineers and operations managers, resulting in a shorter time to market at a lower total cost.
It provides a unique safety concept to the healthcare worker and helps the pharmaceutical company to differentiate from its competitors.
Recent developments in terminal sterilization of delicate products such as PFS have made it possible to acheive sterility faster while maintaining both the uniformity of temperature and the integrity of the containers.
They also made it possible to ensure a cool and dry load quicker after sterilization. The presentation will cover the specificities of PFS and present a case study of one of the most difficult products to sterilize
Flexible Production Systems for Biological Products Utilizing Pre-sterilized Container in Nests (Otto Feil)
Considering the partly small batch sizes for biological products pre-sterilized containers in nests such as syringes, vials and cartridges are a valuable alternative for pharmaceutical operations.
Processing systems for nested containers including a variety of different dosing systems (piston pumps, time-pressure, peristaltic pumps incl. partly disposable dosing size parts) provide a high level of flexibility and are therefore well-suited for such applications.
Our presentation will touch base particularly on the following subjects:
- Concepts for room classifications when processing pre-sterilized containers in nests
- Debagging solutions (semi-automatic and fully automatic) Decontamination possibilities for tubs (e-beam, pulsed light, plasma, etc.)
-Delidding solutions (semi-automatic and fully automatic)
- Available filling technologies (piston pumps, time-pressure, peristaltic pumps as well as disposable solutions)
- Available closing technologies for differently treated closures (siliconized, teflon coated, etc.)
- Vacuum-assisted filling and closing processes Process inspection and monitoring capabilities (load cells, vision systems, laser scanning)
Automatic Inspection for Pharmaceutical products, from contaminants detection to measurement and characterization in real time (Andrea Sardella)
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.
Its will provide a feedback on the quality level and nevertheless on the production process itself characterizing the type of contaminants and reducing substantially the false reject due to bubble presence or colloidal aggregation typical of biotech drugs. In this session we will present the results obtained applying this technology on different product formulations and the benefits for the manufacturing.