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Rommelag Pharma Service: Patent formula for qualification and validation

Highest requirements, strict guidelines, country-specific differences - there are many things to consider in pharmaceutical production. With our tailor-made qualification concept, you will easily overcome all hurdles! And we can do it more cost-effectively and faster than you could on your own.

Customized qualification and validation

Rommelag Pharma Service (RPS) offers an overall coordinated concept. But when it comes to the scope of our services, you have a choice. The best thing to do is to approach us as early as planning. It's worth it!



  • Provision of templates for the qualification of your bottelpack machine
  • Consideration of available machine specifications (URS, FS, etc.)
  • Optional: Risk analysis


  • Provision of templates for the qualification of your bottelpack machine
  • Consideration of available machine specifications (URS, FS, etc.)
  • Workshop before factory acceptance test (FAT) with draft documents
  • Consulting during FAT (Pre-IQ and Pre-OQ)
  • Consulting during IQ and OQ
  • Optional: Risk analysis


  • Provision of all test protocols (Pre-IQ, Pre-OQ, IQ and OQ)* for the qualification of your bottelpack machine
  • Consideration of available machine specifications (URS, FS, etc.)
  • All tests*
  • Any report*
  • Optional:
    • Risk analysis
    • SIP validation
    • Airflow and Particle Mapping Study
    • Cleaning procedure during FAT

Created or carried out by us and approved by you


Get there faster: Fast track concept

Conservative approach:

  • FAT/commissioning tests are not used for qualification
  • Qualification begins as soon as the machine is ready for production

With the RPS Fast Track concept:

  • Qualification documents are prepared in time before the FAT
  • Tests performed during FAT are documented in GMP-compliant records and assessed for use in qualification
  • FAT tests relevant for qualification become pre-IQ or pre-OQ tests.
  • Commissioning tests relevant to the qualification to become IQ or OQ tests
  • Fewer tests are required during the official qualification phase

Thinking of everything: additional pharmaceutical services

With us, good service accompanies you throughout the entire life cycle of your pharmaceutical production. Because: We think holistically and beyond our bottelpack systems, design long-lasting machines and still have modifications in mind, as well as the re-qualifications that go along with them. Open up the full potential of Rommelag Pharma Services!


Qualification of other machines and equipment

No question: A bottelpack system is the core of your BFS production, but the entire GMP environment must be right for regulatory approval. For the qualification, we are happy to offer you the preparation of all necessary documents and the execution of the tests. Likewise, we advise and support you during validation. For example, in these applications:

  • Ventilation/HVAC
  • Clean rooms
  • Ultrapure media
  • Preparation of approach
  • Autoclaving
  • In-process control
  • Secondary packaging

Requalification after modification

Quality assurance always has top priority. Therefore, facility modifications that potentially impact qualified status require reinspection and acceptance. We support you with a qualification and risk analysis. Ask us for an individual offer for your modification and equipment type.

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Consulting for factory and machine planning

We not only develop BFS aseptic filling machines but are contract manufacturers ourselves. Therefore, we know the ideal "workflow" of BFS production and all GMP guidelines. Take advantage of this know-how and benefit from our comprehensive RPS Consulting:

  • Sifting and optimization of the factory layout
  • Review of cleanroom classifications and planned routes for personnel, materials and waste.
  • Summary of all observations and suggestions in a report

Other possibilities would be:

  • Calculation of the personnel and material balance
  • Preparation of technical specifications (URS according to GMP standards) for downstream filling equipment
  • Proposals from suitable suppliers
  • Estimation of the budget based on the analyses and recommendations

Auditing and consulting

We can look back on numerous successfully passed audits conducted by various authorities. These include FDA, EU, PIC/S and WHO, but also many country-specific authorities. We will gladly accompany you to your goal with these services:

  • Carrying out pre-inspections
  • Support in the planning and implementation of workshops in preparation for inspections
  • Auditing of your machines and facilities, for example, after major changes in internal management structures
  • GMP and process optimization

Contact? The sooner, the better!

We can only provide you with the best advice and solution if we understand your requirements. We are equipped to handle everything from BFS packaging and equipment to contract manufacturing and development to full-scale BFS production. We eagerly await your challenge!

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Thank you for contacting us. How can we help you?