When it comes to quality control in Biopharma, there are specific challenges in developing single-use sampling systems”, says Heinz Christian Rost, Market Unit Manager Life Sciences at Parker. “Perfectly protecting the quality of the sampled product and eliminating the risk of contamination is our driving force: our newly developed features are taking out all the risks of daily sample handling.”

Trusting product integrity

Parker has developed the patented “integrity seal”, which is preventing the cap of a sampling system from being opened. “Trust in the integrity of the sampled product is the cornerstone of any decision that our customers are making when reviewing quality control results – from R&D to final fill,” Rost points out. “The ‘integrity seal’ is an elastomeric band encompassing the contai-ner cap and body interface. It is generating a manipulation-proof bonding between the two. The result is a truly closed system.” Next to this, secure tamper proofing and reopening is possible in container variants with elastomeric bands bonded to both the container cap and neck, that are connected via an elastomeric bridge. “This new sampling system is giving our customers the full flexibility in sample handling, providing excellent product protection, even at ultra-low freezing temperatures.”

Open architecture

“Very gentle fluid handling is vital for limi-ting the stress that the product experiences.” Rost adds and highlights that manual connections between the elements of a Parker takes out all the handling risks of sampling systems in upstream, harvesting and downstream bioprocessing sampling system are avoided. “We provide systems with seamless tubing integration that mitigates the risk of leakage and contamination, from component to tubing to container.”

Parkers engineered sampling systems are fully customizable and scalable. “Integrating components, that are already known and trusted by our customers will mitigate concerns on product contact materials, such as Extractable or Leachable Profiles – and you have minimal validation costs,” he continues. “Containers, bags and tubes can be custom-combined to a technologically perfect fit to our customer´s sampling objective.”

“The need for acceleration in the development of biopharmaceuticals is increasing, as we have seen with Covid,” Rost says. “Protecting the products’ integrity during quality control processes, from R&D to final fill through engineered single-use sampling systems, is contributing to a fast-paced, first-time-right commercialization.”