Fabiano Nicoletti & ISPE Indonesia Affiliate

The construction of a pharmaceutical factory is a difficult undertaking, because of its technological complexity, of regulatory constraints, of organisational, financial and time issues and of the objectives to be achieved.

Among those desired objectives, flexibility ranks high but it is a notion which is difficult to define, as everyone has a different view on it..

What is understood by flexibility depends on the project: new or existing products, small-scale or large-scale project, existing or innovative technology, conventional or biotech products, live organisms or not, range and quantities of products, etc. whereby the success of the undertaking will depend on the vision of the project holder and the capability of the planning team.

The speaker will try to come closer to a definition, by highlighting some of those issues and giving corresponding examples.

Kalbio Global Medika constructed a state of the art facility in Cikarang, Indonesia.

This facility won an honorable mention in the ISPE Facility of The Year Awards (2016)

Part of the innovation of this facility was the installation of the first sterile product isolator in Indonesia.

This presentation would describe the design and the challenges we faced and how OMPI helped us with solving the issues surrounding the RTU sterile syringes.

In recent years, along with the development of biopharmaceuticals and self-administration devices, more reliable and safe packaging containers are required in the pharmaceutical industry. In particular, the value of glass as a parenteral primary packaging material has been rediscovered, and at the same times the requirements for glass, such as chemical durability, appearance and dimensions, are increasing more and more.

Nippon Electric Glass (NEG) is supplying TYPE I borosilicate glass tubing all over the world for more than 65 years. I will introduce the characteristics of TYPE I glass tubing, “BS”, “BS-A” and “BS-A Dark”. Our products have high chemical durability and are friendly to humans and the environment in terms of hazardous chemical substances. For amber glass, we supply two color types of glass to respond to diversifying customer demands, ultraviolet shielding ability and ease of visual inspection after filling a medicine.

NEG believes that quality is driven by the process. I will also introduce our manufacturing process which we still continue to improve based on many years of experience. NEG will continuously contribute to the pharmaceutical industry through the supply of high quality glass tubing.

The FDA Draft Guidance “Container/Closure Systems for Packaging Human Drugs and Biologics” was issued in 1999.  But in the past decades, there has been a change in the scrutiny of the FDA reviewers looking at E&L data.   They have gradually increased the requirements, not backed up with any official document (Guidance, guideline…) which left the Pharmaceutical Industry in the dark, second guessing of what the current position and requirements were of the FDA to support a submission.

In this presentation, the key factors of success of any given E&L project will be highlighted.  Crucial is to understand what regulators really want and aligning the design of an E&L study to their expectations.

Facing the reality of the ever-evolving regulatory landscape, analytical testing labs need to be on the forefront with expertise in the field of extractables and leachables testing and state-of –the art technology.  Meeting the development needs and requirements, of the pharmaceutical and biopharmaceutical industries, also raises the bar for material suppliers.

Only through successful partnering between drug product manufacturers, material suppliers and the CRO performing the study, a true mitigation of the risk related to packing can be established. 

The drug product picks the packaging. The presentation will give a brief introduction into the material makeup and production process of an elastomeric closure for pharmaceutical use. It is the primary closure which would be in direct contact with the drug formulation over the drug product’s shelf life, which makes it a critical component of parenteral packaging. We will look into various important aspects to consider when selecting a suitable closure, i.e., compatibility, safety, package integrity and functionality performance, as well as testing considerations to qualify and justify the suitability of the chosen closure for the drug product.

Fat emulsions and freeze-dried products are always more present in the market: advanced applications are required as they are challenging, difficult-to-inspect drugs. Their characteristics can influence the optimum inspection process, but these issues can be successfully overcome using the right applications.

Using the traditional technology to inspect them would not guarantee an adequate result, that is why Stevanato Group has been committed in investing on research and innovation in order to offer the market advanced technological solutions. The presentation will go through the latest technology developed for the inspection of fat emulsions products; special inspection algorithm for freeze-dried drugs, including morphology analysis, and special light sources and application with color cameras.

During the last 2 decades, several systems have been developed and adopted for the cleaning, siliconisation, sterilization and drying of all types of closures (stoppers, plungers, crimp seals), with transfer to isolated filling lines.

Each has their merits, but each is usually dedicated to one style of transfer application: whether processing with off-load to intermediate containers for manual handling, or processing with semi-automatic transfer directly to a filling line.

Steelco will present an innovative, flexible system, the SPE, which can be easily adapted to any of these applications, but also including a fully automatic / continuous processing and transfer system (no human intervention required/no intermediate transfers/no docking of containers). It also provides best in class particulate reduction and drying capability.

When new therapies require products manufactured with smaller volumes in medium-to-low production batches, safeguarding product quality and adopting flexible production methods are essential. INJECTA, IMA Life’s innovative approach to handling Ready-To-Use components, ensures a high degree of flexibility thanks to the intensive use of advanced robotic-driven manipulations and responds to the challenges posed by the increasing complexity of new drug substances improving product quality and manufacturing efficiency.