In reaction to breaches of data integrity in the pharmaceutical industry, regulatory authorities have introduced inspection approaches or initiatives with the aim of reducing occurrences of data integrity problems. In fulfilling their mission to protect public health, regulatory agencies must establish confidence that medical products they approve are fit for their intended use. In so doing they rely on scientific and operational data generated during research, development, manufacturing, sales, marketing, distribution, and post-marketing surveillance activities. Validation of computerized systems is an important part of ensuring decisions are made using complete, accurate and reliable data but is only a small part of data integrity. The complete data lifecycle must be considered and the risk associated with each step need to be evaluated and handled. From the available first draft guidance all decisions within pharmaceutical and device industries must be made based on scientifically sound data. Having gathered the data (not just data but also records in both paper and electronic formats), it must then be maintained and controlled to provide assurances that the data have not been changed inadvertently or deliberately. Data integrity and the use of technology is under scrutiny now more than ever. In recent years, it has really entered the limelight. Inspectors understand that an investment in technology is not always the best way forward for a company but despite that consider that inspectors will want to see that controls are in place for the systems and processes you use. Data Integrity requires that appropriate Quality Metrics are measured, recorded, trended and reported. It is now your time to invest/change?

Glass for Pharmaceutical containers keeps increasing, especially for new applications such as prefilled syringes, which are the primary way for delivering new drugs. This material has indeed fundamental advantages mainly in terms of chemical inertness, transparency, coloration and possibility of high-temperature sterilization.

The purpose of this presentation is to review the main features relevant to the use of glass for pharma.

The pharmacopoeia’s requirements for containers are first considered and a definition of the most common glass types provided. The current glass-tubing and containers production processes will be presented together with the chemical resistance of glass and its implications for the storage of pharmaceuticals. Significant interactions between the container internal surface and the enclosed therapeutic agents will be briefly reviewed, with some considerations from the perspective of glass manufacturers. An account on the current internal and external treatments to improve the chemical and mechanical performances of the containers is provided. Finally,  the most recent regulatory updates on glass for Pharmaceutical uses will be examined.

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 60 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.

Glass is the worldwide traditional material of choice for parenteral containers and it is perfectly responding to the complex needs of the pharmaceutical market that is spurring developments manufactures of parenteral packaging. Manufacturing process of glass primary packaging based on a quality by design approach can contribute to reduce waste of drug filled containers.

This presentation explains the innovations applied in the  manufacturing process of Glass primary packaging in order to reach high quality suitable for injectables in vials, prefillable syringes and cartridges. Characteristics and implementation of glass containers manufacturing are illustrated from bulk process to EZ-fill. No glass to glass, no metal to glass, 100% inline camera controls, are key factors to increase converting quality process . Ready to fill primary packaging has become a standard option in the aseptic manufacturing process. In the past one of the reason for a slow adoption of ready to use were mainly the cost for units and limited technological options. The cooperation of manufacturers with machine suppliers and pharma companies pushed for the development of new configurations in the primary packaging. Leveraging its experience in the manufacturing of sterile, ready to fill platform, Ompi designed and introduced nested sterile ready to be filled products & solutions compatible and innovative for highly performing fill&finish machines.

Accidental needlestick injury is an ever-present danger for healthcare professionals and patients. Growing awareness over the years prompted major countries to take protection and preventive measures against needlestick injuries.

Pharmaceutical companies now require a safety device to be included in their PFS product offering if they need to export to these countries.

It becomes important to understand the features of safety devices, the regulatory requirements, and the manufacturing and assembly modifications.

In a world where time-to-market is essential, or even better speed-to-market, flexibility in production is the buzzword, but there are many significations to that word, and many company or situation specific technical solutions, depending if you have new or existing facilities, small or large quantities, etc; the presentation will highlight some of the potential approaches.

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.

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.

The main reason for going new ways is the great transformation, in Media, Consumer goods, Financial services and Communication. Currently, we see a trend for more biotechnology products and individual therapies for patients. The variety of products increases drastically and many of them are very potent. Therefore, our machines have to be highly flexible to process this products, containers and batch sizes. It has to be recognized that the life cycle of products will be much more dynamic and new product varieties and containers have to be processed. This calls for more flexible and reconfigurable solution that will enable the life cycle management.

The pharmaceutical demands on machine manufacturers are steadily increasing. In the recent past, clean room classifications (RABS / isolators) and sterilization processes (UV / H₂O₂ / Plasma / e-beam) were the main focus. Today dosing systems (rotary piston pump, time pressure, peristaltic pump) and stoppering are of great importance. Another trend of prime importance is the demand for automatic and 100% IPC.

Nested syringe machines must thereby provide a wide variety of performance options.

Established syringe manufacturers are now offering nested cartridges and vials. Machine manufacturers need to act on such trends with sophisticated and flexible solutions.

The big challenge when developing a syringe processing line is the handling of different objects such as syringes, vials and cartridges on a single machine.

All these objects are supplied pre-sterilized in trays. 

Multi use filling machines for ready-to-use components are the new trend in the pharma industry.

Today smaller batch size and higher value products are used compared to previous larger batch sizes.

Optima pharma has realized the demands and has established a high flexibility to process ready-to-use components on one machine (Multi use filling machines).

“We see ourselves as an agile, platform based customizer”

• The market of self-injection devices and recent trends
• How to safe time-to-market when developing a custom injection device
• How to maintain the highest quality at affordable cost
• Examples of recent device projects and lessons learned

Each inspection technology (manual, semi-automatic and fully automatic) presents pros’ and cons’. Starting from this evidence, the presentation will outline the differences and go through the latest methods for the inspection of vials, cartridges and syringes developed by Optrel, illustrating different available controls: particles and cosmetic inspection and container closure integrity.