CDMO: Pharma Contract Filling and Development with BFS

Rommelag CDMO provides quick and efficient access to our Blow-Fill-Seal (BFS) filling technology without the need to invest in your own bottelpack aseptic filling machine. Whether you need to cover production peaks, require full-scale market batch production, or want to convince yourself of our filling technology with laboratory and pilot batches - we are your reliable partner and accompany you from the initial idea to the final product ready for sale.

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

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.

Trials and Scale-Up

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

Analytics

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)

Container Design

Development and optimization of primary packaging molds, material selection, and custom mold design tailored to your specific needs.

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.

Lab Batches

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

Pilot Batches

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

Final Tests & Documentations

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

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 EMA and US FDA
Regular audit approvals by ANVISA for sterile products
Further irregular approvals, e.g., UAE, Belarus, Taiwan, South Korea, KSA, Japan

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