Aseptic bag filling: 5 ques­tions for Chris­tian Kollecker

In August, Harro Höfliger‘s new plat­form for aseptic bag filling was launched. Chris­tian Kol­lecker, Director Aseptic Tech­nolo­gies, answers the ques­tions about “baX­eptic”.

Aseptic machine engi­neering is nothing new at Harro Höfliger. What makes baX­eptic special?

The new word mark baX­eptic is made up of the words “bags” and “aseptic” and already gives an indi­ca­tion of the two main aspects: The aseptic filling of liquid prod­ucts into pre-ster­il­ized bags, which must not be con­t­a­m­i­nated under any cir­cum­stances during the filling process. More and more com­plex phar­ma­ceu­tical prod­ucts with large mol­e­cules and high filling vol­umes are admin­is­tered via infu­sion. Existing process solu­tions, how­ever, often do not meet the require­ments for flex­i­bility and GMP-com­pliant hygiene design. With ­baX­eptic, the customer’s appli­ca­tion deter­mines the tech­nical solu­tion and this is where we come in. We can draw on a wide range of proven tech­nolo­gies and more than 30 years of expe­ri­ence in the design and con­struc­tion of aseptic pro­duc­tion machines.

What types of therapy do you have in mind?

Gen­er­ally speaking, the market for aseptic bag appli­ca­tions is growing world­wide. In par­tic­ular, we are tar­geting bio­phar­ma­ceu­ti­cals and new ther­a­pies with gene- and cell-based ingre­di­ents that have great poten­tial to cure chronic and serious dis­eases. It is a fore­gone con­clu­sion that ter­minal bag ster­il­iza­tion after filling is out of the ques­tion for bio­mol­e­cules and liv­ings cells. Due to the small batch sizes, the pro­duc­tion and filling of per­son­al­ized med­i­cine requires a max­imum degree of product and process reliability.

Key­word process reli­a­bility: How do you ensure it?

First and fore­most baX­eptic is about meeting cus­tomer require­ments which are usu­ally deter­mined by the product and the pri­mary pack­aging mate­rial. At the begin­ning of the tech­nical con­cep­tion, we are in close con­tact with the cus­tomer, so that we can com­bine their process expe­ri­ence and knowl­edge about product and pri­mary pack­aging mate­rial with our exper­tise in building aseptic bag filling lines. This is the basis for achieving a robust and reli­able solu­tion. Not only the filling process itself is impor­tant but the overall under­standing of processes from bag feeding to han­dling, filling and sealing, all the way to process ana­lyt­ical testing. This under­standing must then be trans­ferred to an aseptic system, taking into account the applic­able stan­dards and reg­u­la­tions. In the lab­o­ra­tory of our Pharma Ser­vices depart­ment, liquid media can be tested in order to find optimal processes at an early stage. Our cus­tomers ben­efit from our phi­los­ophy “From lab to pro­duc­tion”, which means scal­able processes. At the same time, baX­eptic also enables scaling-out, where mul­tiple small-scale lines lead to increased pro­duc­tion capacity.

Are there spe­cial baX­eptic machines?

Invari­ably, the customer’s product deter­mines the design, and the end product of our joint effort is always a tailor-made system. This is also due to the fact that there are hardly any stan­dard­ized bag appli­ca­tions. baX­eptic sym­bol­izes the gen­eral method how we develop and imple­ment machines for aseptic bag filling. We use the tech­nology pro­gram of Harro Höfliger and inte­grate aseptic key processes into proven machine plat­forms that can be flex­ibly con­fig­ured. This includes our estab­lished rotary and oval motion machines, but also bar­rier sys­tems with iso­la­tors or RABS with glove ports, sophis­ti­cated con­cepts for product and oper­ator pro­tec­tion, the use of robots for bag han­dling as well as the appro­priate processes for cleaning and decontamination.

What reg­u­la­tions must be observed in aseptic man­u­fac­turing processes?

The man­u­fac­ture of sterile prod­ucts is sub­ject to strict require­ments which ulti­mately ensure patient safety. The most impor­tant reg­u­la­tions are spec­i­fied in Annex 1 on sterile pro­duc­tion of EudraLex Volume 4 of the EU GMP Guide. The revised final ver­sion was pub­lished in August 2022 and will come into force on August 25, 2023. Harro Höfliger has already devised a detailed con­cept for GMP-com­pliant hygiene design, for example about mate­rial and sur­face require­ments, clean­ability and sterile envi­ron­ments – which was doc­u­mented in white papers. Com­pa­nies that take the ini­tia­tive now to pre­pare for the new reg­u­la­tory frame­work, can gain an impor­tant lead in phar­ma­ceu­tical engineering.

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Photos: Helmar Lünig