ABOUT US

Because we are independent from equipment manufacturers, we can focus entirely on turning the regulatory requirement of CCIT into a real benefit for your company.

After many years of working in the field of machine sales, where I gained deep insights into CCIT and pharmaceutical packaging, I decided to start something new. My former customer, Freek Prins, immediately caught up with the idea, and together we founded be integral GmbH.

While I bring the technical expertise in CCIT and engineering, Freek adds more than 25 years of experience in regulatory compliance and pharmaceutical quality systems. His precision, reliability, and structured approach ensure that our solutions are not only innovative but also fully aligned with regulatory expectations.

Our mission is clear: to make CCIT not just another regulatory requirement, but a powerful tool for ensuring packaging integrity, regulatory compliance, and ultimately patient safety.

OUR MISSION STATEMENT

Your advantage

Benefit from the expertise of be integral GmbH, founded by Jens Höllein in 2022 as the only independent European consultancy focused entirely on leak-proofing and container closure integrity (CCIT) for parenteral packaging.

We guide pharmaceutical companies through the dense landscape of regulations and global authority expectations. Working directly with your team, we ensure that your packaging systems meet all approval requirements — and that your medicines remain sterile and effective throughout their lifecycle.

With the support of our additional laboratory services, you don’t just gain solutions — you build lasting in-house expertise.

Let’s talk about how we can support your packaging challenge.

Asking for advice is free. Receiving advice is inexpensive — and the potential savings can be substantial.

If nothing new comes from our conversation, your investment will have been just a few minutes preparing your request and half an hour discussing your issue.

#CCIT

Container Closure Integrity Testing (CCIT) assesses whether a primary packaging system reliably maintains its seal — protecting not only the product, but also the patient, the user, and the environment.

Integrity is essential to ensure sterility, stability, and safe handling of parenteral drugs. The container must prevent leaks, microbial ingress, and the intrusion of gases such as oxygenand moisture, which can degrade sensitive formulations.

But CCIT is more than a regulatory requirement. It’s a powerful process insight tool. Properly implemented, CCIT helps you detect risks early, identify process drift, and respond before quality is compromised.

Trending shifts in CCIT data are never random — they are early warnings. Failures don’t come from good processes. That’s why doing CCIT right doesn’t just satisfy compliance — it strengthens your process control and reduces long-term risk.

LET’S WORK TOGETHER!

Our Services

Welcome to be integral, your trusted partner for comprehensive leak testing solutions in the pharmaceutical industry. We support our clients across the entire product lifecycle with specialized services in Consulting, Laboratory Services, and Distribution.

Consulting

Laboratory Services

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TESTIMONIALS

What people say about us

„be integral GmbH was our partner for the development and validation of CCIT-methods for differs Leo-formats. We were fully satisfied with the whole project, including the consultancy, the design and concept of the study and protocols and the communication with be integral. They helped us very much to get the method implemented in our routine work, quickly and smoothly. We would consider be integral for future project and recommend be integral GmbH to other companies with similar topics“

Annegret Karwot
Head of sterile dosage forms ・
Mibe GmbH pharmaceuticals

„It was a short but intensive collaboration with Jans Höllein, the CCIT specialist, to find a basis for the decision regarding implementation of CCIT. Mr. Höllein was able to familiarize himself with our special product requirements in a very short time incorporate, raise the right questions and pick up the entire internal team to find a solution here, which ultimately became the basis for decision-making for the company.“

Susanne Ambrosi
Head of Commercial・
BAG Health Care GmbH

Our Team

Jens Höllein

Jens is the technical lead and co-founder of be integral GmbH. With nearly 15 years of experience in pharmaceutical packaging, he specializes in container closure integrity (CCIT) from both the engineering and strategic sides.

His work ranges from developing full test setups and custom machine solutions to advising clients on how to build a sound, product-specific CCIT approach. Creative by nature, he thrives on turning complex challenges into workable systems.

“If our work prevents even a single case where a drug loses its efficacy due to an insufficiently tight container — that would mean the world to me.”

Jens is also a recognized CCIT trainer — known for explaining even the most technical topics with clarity and calm.

Freek calls him “the creative force that pushes our solutions beyond the standard.”

Freek Prins

Freek is co-founder and general manager of be integral GmbH. With over 25 years of experience in the pharmaceutical industry, he brings deep regulatory insight and a sharp eye for compliance. He is responsible for the creation and control of all documentation — ensuring that every step we take meets the expectations of regulators and the needs of quality systems.

Freek is the strategist behind our processes, the one who translates complex requirements into clear, practical procedures. Known for his structured thinking and calm communication, he brings clarity not only to clients, but to our internal work.

As Jens puts it: “He brings the structure that keeps our ideas focused and on track.”

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Contact us

Gernotstraße 23
44319 Dortmund

Email: info@be-inegral.com

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