Containment Solutions
Process highly potent/highly effective active ingredients in a safe production environment
We make your systems fit for new requirements
The development and use of highly active pharmaceutical ingredients, both biotechnical APIs and chemical APIs, is constantly increasing. This is associated with increased demands on containment when handling and processing the substances.
We support you in your responsibility for people, products and the environment and work with you to find the suitable combination of the right level of containment and efficient production. Containment considerations and an appropriate containment strategy already play a central role in the early project phases.
Processing YOUR highly active pharmaceutical ingredients in a safe production environment
Ensuring product quality, such as avoiding cross-contamination, and guaranteeing occupational safety and environmental protection are in the focus of our considerations. Thereby, the required safety measures for production are based on a risk assessment developed by the customer. Right from the beginning we take the approach of developing and evaluating concepts together with you, the customer, and working out the most suitable concept for your specific project.
Maximum product safety and occupational safety by tailored risk-based approach
The exposure level of the substances (Occupational Exposure Limit) and the procedural and process-related risks determine the necessary containment measures. Our specialists will support you by analyzing the risks in your process environment and determining the hazard potential within your risk assessment.
Factors such as substance quantity, duration and frequency of exposure play a key role in deriving the necessary containment measures.
Following the (S)TOP method, we first concentrate on developing a suitable primary containment solution. Of course, we also have the expertise to support your needs for secondary containment, such as suitable room and airlock concepts or pressurized zone and HVAC concepts.
Containment Facts for the decision-makers
- For pharmaceutical production, the trend toward increasingly potent active ingredients results in mounting personal protection requirements for operating personnel.
- Aside from the toxicological data for the active ingredient, operator exposure as well as frequency of production cycles also play an important role.
- Efficiency and cost-effectiveness criteria must always be examined to determine whether investment in system technology is worthwhile or whether procuring personal protective equipment for the operator makes more sense.
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Link to: High containment for solid drugs
Published article: ‘High Containment Processes in the Solid Drugs Production’
Link to: High containment for solid drugs
Copyright: Vogel Communications Group
Link to: High containment for solid drugs
Containment of a solid drugs production is incomplete where the production environment is neglected. Closed process equipment and the production environment need to be considered as an integral solution. There should however be a reasonable balance between protective effects and plant productivity. Glatt Process & Plant Engineering develops and provides integrated system solutions for high containment processes.
Apart from personnel and environmental protection, operators of high containment processes put emphasis on product protection. Simultaneously a high productivity of process equipment is required. Problems arise where protection requirements conflict with production capacity and equipment availability. Times for product transfer and cleaning at product change play a decisive role in this conjunction.
- author: Torsten Hetzer, Senior Project Engineer, Glatt Ingenieurtechnik GmbH
- originally published at process-worldwide.com, Vogel Communications Group, May 2013
Link to: Success Factor Containment – Safe contract manufacturing with zero contamination
Published article: ‘Success Factor Containment – Safe contract manufacturing with zero contamination’
Link to: Success Factor Containment – Safe contract manufacturing with zero contaminationCopyright: Vogel Communications Group
Link to: Success Factor Containment – Safe contract manufacturing with zero contamination
Contract manufacturers are working with challenging customers and require highly sophisticated equipment. Corden-Pharma is now going the extra mile. With the construction of a new, fully-contained development lab for high potency compounds, covering all manufacturing process steps for the development and production of tablets, the company is able to achieve unequaled OEL (Operator Exposure Limit) levels of less than 1 μg/m³. This is the first step towards zero contamination.
The demand for the formulation of highly potent compounds, especially for cancer treatment, remains high, not only for parenterals but also for oral solid dosage. There is a high need for the manufacture of highly potent oral solid dosage forms. Some estimate that oral oncology drugs have doubled in the past ten years.
- author: Axel Friese, Head of Marketing, Glatt GmbH in Binzen, Germany
- originally published in the magazine ‘PROCESS Worldwide’, issue 6/2017, Vogel Communications Group
Link to: Containment solutions only cost-effective when adapted
Published article: ‘Containment solutions only cost-effective when adapted’
Link to: Containment solutions only cost-effective when adapted
Copyright: Glatt
Link to: Containment solutions only cost-effective when adapted
XXL EFFECTIVENESS IN A SLIM-FIT SUIT
Containment comes at a price. Equipping plants completely for compliance with the highest containment level, OEB 5, is extremely expensive. Yet a crucial fact is often overlooked: the hazard level posed by an active ingredient to employees varies along its route through the plant. This insight can be exploited by adapting containment solutions to the respective requirements in each area.
Currently one in four active pharmaceutical ingredients (API) is classified as “highly potent” and this upward trend is expected to continue. This is attributable to a trend towards administering increasingly potent substances in ever smaller doses – such as in the case of personalized medicine. This impacts pharmaceutical production in the form of rising personal protection requirements for operating personnel. Full-protection hazard suits are one option, however they have several disadvantages: on one hand, they are often impractical and uncomfortable to wear, and on the other, are often very expensive when examined from a full costing perspective. Moreover, significant labor costs result from putting on and removing the suit.
- author: Axel Friese, Head of Marketing, Glatt GmbH, Binzen, Germany
- English Re-Print of the german article, originally published in the magazine ‘Pharma+Food’, issue 03/2016, Hüthig GmbH
Link to: New Challenges for Material Handling in Pharmaceutical Production
Published article: ‘New Challenges for Material Handling in Pharmaceutical Production’
Link to: New Challenges for Material Handling in Pharmaceutical Production
Copyright: Hüthig GmbH
Link to: New Challenges for Material Handling in Pharmaceutical Production
A holistic look at the supply chain
Production units are high on the list of priorities that need to be considered when designing pharmaceutical systems. With demands on flexibility and automation growing, material flow and production handling are becoming increasingly important factors in improving efficiency. Only through integrated material handling can flexible and automatable systems be created.
There is potential for optimization when transferring products between process steps. The trend in favor of flexible systems for highly potent active ingredients requires sophisticated solutions. New technologies make it possible to virtually eliminate handling errors.
- author: Erich Nussbaumer is material handling expert at the pharmaceutical technology specialist Glatt GmbH, Binzen, Germany
- English Re-Print of the german article, originally published in the magazine ‘Pharma+Food’, issue September/2019, Hüthig GmbH
Further information on this topic and related topics can also be found in the following publications:
Link to: Outsourcing der Produktion – Vertrauen in kompetente Partner
Copyright: Glatt
Published article: ‘Outsourcing – Trust in competent partners’ PDF, English
Link to: Avoiding mistakes in cleanroom constructionCopyright: Vogel Communications Group
Published article: ‘Planning is everything. Avoiding mistakes in cleanroom construction’ PDF, Englisch
Link to: The design and modularisation of API synthesis plantsCopyright: HPCi Media Limited
Published article: ‘The design and modularisation of API synthesis plants’ PDF, English
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