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Highest product quality for pharmaceuticals

Bosch Inspection Technology Highest product quality for pharmaceuticals By Joachim Baczewski, President of Bosch Packaging Technology K.K. in Japan and Head of Inspection Technology

Feature – Bosch Inspection Technology
By Joachim Baczewski, President of Bosch Packaging Technology K.K. in Japan and Head of Inspection Technology

Highest product quality for pharmaceuticals

Growing production capacities, complex manufacturing processes and high production speeds are changing the pharmaceutical landscape all over the world. At the same time, the production of pharmaceuticals underlies increasingly strict safety regulations. They determine highest product quality to protect patients from contaminated medicine. Manufacturers are able to meet this challenge by using future-oriented inspection technologies.

Complying with strictest quality and safety regulations is especially important for parenteral products filled in vials, ampoules, syringes and cartridges. Other liquid pharmaceuticals, as well as solid dosage forms such as tablets and capsules must also undergo thorough inspection. Sophisticated inspection technologies are used, for instance, in the development of biotech products and anti-cancer treatment. They are able to evaluate processes in real time, to detect and quantify process- or component-related defects and to take corrective actions.

Product contamination occurs when particles or foreign matter are found within a pharmaceutical. Contaminated pharmaceutical ingredients, foreign matter or filling material might get into the product during manufacturing or filling operations. Cosmetic container defects, such as cracks in syringe flanges or defects in the sealing integrity of ampoules, might either already be present or occur during handling. The choice of suitable inspection technologies depends largely on product consistency, form and size of the containers. Manual, semi-automated and fully-automated systems are used either for the detection of product-related contamination, cosmetic container defects, or both.

From manual to fully automated
The United States Pharmacopeial Convention (USP ) requires that particulate and other foreign matter visible to the human eye shall not be present. A human inspector can detect approximately 50 percent of all particles sized 50 micron. He therefore physically agitates each container to set the liquid and any possible contaminants into motion, and to subsequently inspect each individual container carefully. Semi-automated inspection systems minimize the need for manual handling. The automatic feeding, sorting and discharging functions facilitate the inspector’s work and enable him to focus entirely on the quality control of containers.

Some automated inspection systems are able to detect particles below the human capabilities. The "static division" (SD) technology, for instance, projects light through the liquid onto an optical SDx sensor, leading to the differentiation of static from moving objects. Automated camera-based systems, in turn, are used for both particle and cosmetic inspection. While the containers are agitated and rotated by more than 360 degrees, cameras take a series of high-resolution images. By comparing these images, the system can also identify particles stuck to the sidewall, as well as crimp or sealing defects.

Integrated product quality
The Process Analytical Technology (PAT ) guidance, issued by the American Food and Drug Administration (FDA) in 2004 triggered the development of entirely new inspection technologies, especially in the area of solid dosage forms. PAT is "a system for designing, analyzing, and controlling manufacturing through timely measurement (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality."

The main focus of PAT is "building quality into products", instead of inspecting quality after the product has already been manufactured. Machines with x-ray technology, for example, are suited for this purpose. They enable comprehensive quality and weight control, for instance of capsules. New software developments and imaging capabilities contribute to a rapid advance of these technologies. Most recently developed inspection units are able to simultaneously check all quality features like weight, foreign particles, deformation of capsule top and bottom, as well as length in real-time and at high throughput rates.

Combinations on the rise
Parenteral products are typically injected and go directly into the bloodstream, where they might cause adverse reaction to contamination and particles. The EU Guideline to Good Manufacturing Practice (GMP), Annex 1 states that "filled containers of parenteral products should be inspected individually for extraneous contamination or other defects." It further emphasizes the need for validation where other than visual inspection methods are used.

Within the validation process of fully-automated inspection machines, samples are crucial to ensure that inspection machines also maintain their validated state under dynamic conditions. Manual and semi-automated inspection tools are especially suited to inspect these samples. They are mainly used for small batch sizes, laboratory analyses, re-work of ejects, and benchmarking of fully-automated machines.

The key to pharmaceutical quality
Due to the growing number of parenterals and especially generic products, manufacturers require ever faster machines for larger production quantities. Here, manual inspection is quickly stretched to its limits. Even the best-trained human inspector cannot keep up with the high speeds of all production types. Depending on size and type of the pharmaceutical product and container, a combination of automated and manual inspection is sure to be the most reliable approach.

To ensure that inspection machines operate at their best, manufacturers must pay attention to validation requirements and perform regular maintenance activities. They must also carefully monitor their processes and regularly check new regulations and guidelines, as well as the availability of new technologies. The possibilities of inspection technology are immense. Therefore the decision for robust and reliable technologies from high-quality suppliers is of utmost importance for high product quality and best possible patient safety.

ENDS

Contact
Joachim Baczewski
Bosch Packaging Technology K.K.
Head of Inspection Technology
Tel. +81 (3) 5466-2550
E-mail: joachim.baczewski@bosch.com

About Bosch Packaging Technology – Business Unit Pharma
Bosch Packaging Technology – Business Unit Pharma is one of the leading providers of process technology and packaging solutions for the pharmaceutical industry. The portfolio includes single units, integrated systems and complete solutions for the manufacturing and processing of sterile and non sterile liquids and powders. Furthermore, it comprises primary packaging machines for sterile fill finish of pharmaceutical liquids and solid dosage forms, secondary packaging equipment as well as inspection technology, qualification, validation and services. The following product brands are part of Bosch’s portfolio for the pharmaceutical industry: Hüttlin, Manesty, Moeller&Devicon, Pharmatec, SBM Schoeller-Bleckmann Medizintechnik, Sigpack and Valicare. For more information please visit www.boschpackaging.com.