Reasons for Rommelag Consulting

Why Choose Rommelag Consulting?

Rommelag Consulting
As the inventor and global market leader of Blow-Fill-Seal technology, we know every process down to the last detail.
For over 50 years, we have been producing over two million containers daily as a contract manufacturer for global customers. This extensive experience, particularly in the pharmaceutical industry, means we understand all challenges and know the solutions.
We offer a fast, cost-effective, and regulatory-approved comprehensive solution for qualification and validation—from blank documents to full implementation.

We accompany you from the first idea to commissioning and remain a reliable partner throughout the entire lifecycle of your production.

We have a track record of numerous successful audits conducted by various authorities, including FDA, EU, PIC/S, and WHO, as well as many country-specific agencies.

Consulting Services

Overview of our Consulting Services

We offer comprehensive consulting services tailored to your specific needs. All results are documented in a detailed report. Upon request, we also prepare calculations of personnel and material balances, as well as budget estimates.
Conception of Process and Production Structures
Conception of Process and Production Structures

We develop customized processes and production structures with optimal bottelpack systems and cleanroom integration. We carefully plan workflows and auxiliary functions so that all processes run seamlessly.

Determining Your OEE Value
Determining Your OEE Value

By assessing your current Overall Equipment Effectiveness (OEE) value, we can identify opportunities to significantly increase your bottelpack system's efficiency.

Auditing Your Facilities and Equipment
Auditing Your Facilities and Equipment

We audit your systems and facilities, especially after internal changes. This ensures that all processes run optimally and comply with current requirements and regulations.

Reviewing Cleanroom Classifications and Process Concepts
Reviewing Cleanroom Classifications and Process Concepts

Our experts analyze your cleanroom classifications and personnel, materials, and waste paths to ensure the highest hygiene standards and product safety.

Developing Technical Specifications
Developing Technical Specifications

We assist in creating the User Requirements Specification (URS) for up- and downstream equipment according to GMP standards.

Recommending Suitable Suppliers
Recommending Suitable Suppliers

We will introduce you to carefully selected suppliers from our network and accompany you through the selection process on request.

Benefits

Your Benefits at a Glance

Economical and Efficient Operations
Economical and Efficient Operations

Optimal production processes lead to higher productivity, lower production costs, and maximum resource savings.

Optimal Space Utilization
Optimal Space Utilization

We create optimal structures with short pathways. We achieve significant cost benefits through space-saving bottelpack systems and the elimination of storage, cleaning, and sterilization of empty containers.

GMP Compliant
GMP Compliant

We plan according to GMP guidelines, allowing you to rely 100% on your factory being approved by authorities worldwide.

Excellent and Safe Working Conditions
Excellent and Safe Working Conditions

In structure and process development, the safety and well-being of employees are our top priority.

Strategic Personnel Planning
Strategic Personnel Planning

As a contract manufacturer, we have decades of experience in precisely determining personnel needs and the required qualifications.

Built for Growth
Built for Growth

In planning factory structures, we always consider the economy and flexibility of our BFS technology and plan flexibly enough to ensure nothing stands in the way of future expansions.

Women with headset

Ready to Optimize Your Production?

Contact Rommelag Pharma Service (RPS) to find out how our expertise can help you get the most out of your BFS production.

FAQs

Rommelag's Pharma Service Team (RPS) supports the full planning cycle for a BFS production line: conception of process and production structures, cleanroom integration, workflow design, and auxiliary functions, documented in a detailed report with personnel and material balance calculations and budget estimates on request. As the inventor of Blow-Fill-Seal technology, RPS draws its planning expertise from a group that also runs BFS contract manufacturing at scale through its CDMO division, producing over two million containers daily — a different perspective than a general engineering consultancy without that kind of hands-on production experience can offer.

Rommelag determines the current Overall Equipment Effectiveness (OEE) value of an existing bottelpack system to identify concrete efficiency gaps, rather than proposing generic upgrades. The audit covers system performance against defined benchmarks, so any recommendation that follows, whether a process adjustment, modernization of specific components, or a change in operating parameters, is tied to a measured baseline instead of an estimate.

Rommelag's facility and equipment audits are typically triggered by internal changes and check whether processes still comply with current regulatory requirements and run optimally after that change. Because Rommelag's own track record includes audits by the FDA, EU, PIC/S, WHO, and multiple country-specific agencies, the internal audit criteria used are aligned with what these authorities actually inspect, not just Rommelag's own internal standard.