Analytics and process development Approval and registration assistance Contract filling and packaging Packaging development and design Good manufacturing practice Trial fillings

Rommelag CDMO Service Portfolio

Blow-Fill-Seal is the safest and most economical way to get your liquid or semi-solid product into the perfect packaging. However, investing in your own equipment is not always profitable. As an experienced pharma contract manufacturer, we are happy to provide you with our wide range of CDMO services for such cases. These are available to you immediately:

  • A complete GMP infrastructure
  • Bottelpack aseptic filling machines in various configurations
  • Flexible container designs
  • Professional batch preparation for your liquid and semi-solid products
  • Specially trained personnel
  • Decades of experience in pharmaceutical manufacturing
50 +

bottelpack aseptic filling machines

2 M+

daily container production

Contract Filling & Packaging

Aseptic Contract Filling with Blow-Fill-Seal Technology

Leveraging decades of experience, we specialize in aseptic contract filling of pharmaceutical products using our advanced BFS technology

We handle a wide range of liquid and semi-solid products, including injection, infusion, inhalation solutions, and eye drops - regardless of whether they are solutions, emulsions, or suspensions. Our laboratory is also equipped to handle temperature-sensitive APIs safely.

In addition, we fill biopharmaceuticals such as vaccines, antibodies, and anesthetics under the strictest safety precautions. We have BSL-2 certified BFS filling capacities, strict cleanroom protocols, and specially trained staff to ensure the highest quality and safety standards.

If an in-house bottelpack machine is more economical for you but you lack the required GMP environment, space, or manpower, we can set up your machine in our pharma suite and manufacture on your behalf.

Analytics & Process Development

Process Development for Optimal BFS Solutions

Jointly with our extensive partner network, we support you from the early development phase to series production in developing the optimum blow-fill-seal solution for your product.
Our specialists work closely with you from the initial stages, using pilot batches to fine-tune and perfect the process before moving to full-scale production.

We perform sterile filtration tests and facilitate process scale-up to ensure a seamless transition to full-scale production.

We offer you comprehensive microbiological analyses, stability storage and testing, chemical tests, and product analyses:

  • Physical, chemical, and microbial analyses of raw materials and finished products
  • Standard methods from pharmacopeias (such as USP and EP)
  • Customer methods can be transferred (e.g., HPLC for content and purity)
Development and optimization of primary packaging molds, material selection, and custom mold design tailored to your specific needs.
Woman checks BFS ampoule under a test light
Rendering of different blow-fill-seal containers

Packaging Development & Design

Personalized Packaging Development

We offer a comprehensive selection of proven container designs with fill volumes ranging from 0,04 to 1,200 ml. Each design can be modified to your requirements, incorporating features such as practical hanging devices, applicators, or other custom elements.
If our existing options do not fully meet your needs, we can develop tailor-made designs to match your specifications.

We also design the secondary packaging according to your specifications and adapt it flexibly to the product. Bulk and fully automated packaging, including folding boxes, instructions for use, and outer cartons, is possible. We can also implement serialization and aggregation on request.

Trial Fillings

Lab and Pilot Batches

Every product has unique characteristics, so finding the optimal dosage form is essential. 
Trial fillings with lab and pilot batches are used to assess your product's compatibility with the BFS process and determine the most suitable container design.

  • Formulation verification: Proof that the formulation can also be realized at lab scale in our laboratory
  • Product analysis: Examination of the properties of the final product to optimize and plan the following process steps
  • Filling under actual production conditions: Carrying out filling as in final production to define processes and make necessary adjustments
  • Proof that the product and the BFS processes work in the production environment
  • Comprehensive end-product testing: Ensuring that the final product meets all functional and visual requirements
  • Complete documentation: preparation of all relevant documents for product approval
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workers interact with bottelpack machine

GMP

Good Manufacturing Practice

We strictly adhere to Good Manufacturing Practice (GMP) guidelines, and every product is subjected to a thorough inspection. In this way, we ensure that you and your customers receive products of consistently high and reliable quality. This is checked and certified regularly by external audits:

  • Manufacturing authorization and GMP certificate for medicinal products certified according to DIN ISO 9001 as well as DIN ISO 13485 for medical devices
  • Annex 1 compliant BFS filling
  • Regular audit approvals by EMEA and US FDA
  • Regular audit approvals by ANVISA for sterile products
  • Further irregular approvals, e.g., UAE, Belarus, Taiwan, South Korea, KSA, Japan
icon-zulassung-registrierung
Admission and Registration Assistance
Admission and Registration Assistance

Navigating the complexities of pharmaceutical admission and registration can be challenging. Our expert team provides comprehensive support, including extractable and leachable studies, detailed analytical data, and template documents for qualification and validation.

We ensure your products meet all regulatory requirements efficiently and effectively. In addition, we offer clinical trial batches as well as stabilization and approval batches under GMP conditions.

Woman in lab clothes

Discover our CDMO Capabilities

To request our capabilities brochure and find out exactly whether our CDMO services can meet your requirements, please complete the form using the button below.

The Capabilities Brochure contains:

  • Details on suitable product properties
  • Information on possible batch sizes
  • Packaging materials and filling specifications
  • Detailed information on secondary packaging options