Kristin Brooks, Managing Editor, Contract Pharma02.13.18
There are numerous variables influencing pharma and biopharmaceutical packaging today. Not only are the drug products and delivery methods changing, often becoming more complex, regulatory requirements, personalized medicine and compliance trends demand more advanced and flexible equipment solutions.
Packaging equipment needs to address many of these variables, often in one fell swoop, providing efficiency and quality, while offering flexibility to accommodate a multitude of products. Matthias Poslovski, Technical Sales Director at OPTIMA pharma GmbH discusses some of the pharma and biopharma trends impacting equipment needs. --KB
Contract Pharma: What pharma/biopharma trends are impacting packaging equipment needs?
Matthias Poslovski: From the product side, biopharmaceuticals or orphan drugs are gaining more and more importance. Many of the new pharmaceuticals are protein based, very sensitive and often highly potent. This leads to smaller and smaller batches up to lot size one (personalized medicine). Another trend is the greater variety of types and ways to administer the drugs. The self-administration of drugs or safety devices may require special assembly functions within the packaging process. Other APIs can be delivered by oral dispersible films (ODF). The processing of these pharmaceuticals is achieved by combining converting and packaging technologies.
CP: What capabilities do clients look for?
MP: With regards to small sized batches and aseptic liquids, many customers ask for very flexible capabilities in machinery. The machinery should be able to process vials, prefilled syringes and cartridges, and the duration for format changes has to be as short as possible. Or even better, there is no need for format changes at all, by implementing new transport systems or robotics, this is achieved for almost all format sizes and even container types. High flexibility means less down time. If isolator technology or freeze-drying is necessary, which is the case within many projects, the decontamination cycle or the duration of the freeze-drying process has to be addressed. Here, again, we offer new and very timesaving technologies.
CP: Are there any specific challenges clients are looking to address?
MP: In each project, we have several specific challenges. For example, high potent products leading to the highest safety requirements for protecting the machine operators. Another example: cartridges for auto injectors which should be filled and closed 100% bubble-free. Today, many clients ask directly for our capabilities within industry 4.0. They recognize the advantages, mainly the efficiency, within the engineering process, the potential for service, training and operating the machinery, and we have what they expect – or even more.
CP: What are some of the latest advances in packaging equipment?
MP: The 100% bubble-free filling and closing of cartridges, this is an important precondition for the correct dosing when auto injectors are in use or for processing oxygen sensitive products. Furthermore, we have launched our MultiUse Filler systems. They offer the most flexible, automated and safe processing of small to mid-sized batches. Our sister company Metall+Plastic has developed a new technology for further reducing decontamination cycles which is called Decojet. At Achema, the freeze-drying division at Optima Pharma will present a new process for controlled nucleation. It leads to better quality of the freeze-dried product and the potential for new time savings.
CP: What type of equipment is most in demand among clients?
MP: The focus of our customers has clearly shifted to all kind of flexible systems. And as we are a turnkey supplier, many of our projects include filling and closing systems, isolators and freeze dryers.
Packaging equipment needs to address many of these variables, often in one fell swoop, providing efficiency and quality, while offering flexibility to accommodate a multitude of products. Matthias Poslovski, Technical Sales Director at OPTIMA pharma GmbH discusses some of the pharma and biopharma trends impacting equipment needs. --KB
Contract Pharma: What pharma/biopharma trends are impacting packaging equipment needs?
Matthias Poslovski: From the product side, biopharmaceuticals or orphan drugs are gaining more and more importance. Many of the new pharmaceuticals are protein based, very sensitive and often highly potent. This leads to smaller and smaller batches up to lot size one (personalized medicine). Another trend is the greater variety of types and ways to administer the drugs. The self-administration of drugs or safety devices may require special assembly functions within the packaging process. Other APIs can be delivered by oral dispersible films (ODF). The processing of these pharmaceuticals is achieved by combining converting and packaging technologies.
CP: What capabilities do clients look for?
MP: With regards to small sized batches and aseptic liquids, many customers ask for very flexible capabilities in machinery. The machinery should be able to process vials, prefilled syringes and cartridges, and the duration for format changes has to be as short as possible. Or even better, there is no need for format changes at all, by implementing new transport systems or robotics, this is achieved for almost all format sizes and even container types. High flexibility means less down time. If isolator technology or freeze-drying is necessary, which is the case within many projects, the decontamination cycle or the duration of the freeze-drying process has to be addressed. Here, again, we offer new and very timesaving technologies.
CP: Are there any specific challenges clients are looking to address?
MP: In each project, we have several specific challenges. For example, high potent products leading to the highest safety requirements for protecting the machine operators. Another example: cartridges for auto injectors which should be filled and closed 100% bubble-free. Today, many clients ask directly for our capabilities within industry 4.0. They recognize the advantages, mainly the efficiency, within the engineering process, the potential for service, training and operating the machinery, and we have what they expect – or even more.
CP: What are some of the latest advances in packaging equipment?
MP: The 100% bubble-free filling and closing of cartridges, this is an important precondition for the correct dosing when auto injectors are in use or for processing oxygen sensitive products. Furthermore, we have launched our MultiUse Filler systems. They offer the most flexible, automated and safe processing of small to mid-sized batches. Our sister company Metall+Plastic has developed a new technology for further reducing decontamination cycles which is called Decojet. At Achema, the freeze-drying division at Optima Pharma will present a new process for controlled nucleation. It leads to better quality of the freeze-dried product and the potential for new time savings.
CP: What type of equipment is most in demand among clients?
MP: The focus of our customers has clearly shifted to all kind of flexible systems. And as we are a turnkey supplier, many of our projects include filling and closing systems, isolators and freeze dryers.