Rommelag CDMO: Pharma Contract Filling and Development with BFS

Rommelag CDMO provides quick and efficient access to Blow-Fill-Seal (BFS) technology without the need to invest in your own bottelpack aseptic filling machine. Whether you need to cover production peaks or require full-scale market batch production, we are your dedicated partner, supporting you from the initial concept to the final packaged 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. But investing in your own equipment doesn't always pay off. For these cases, we offer a wide range of CDMO services, giving you immediate access to:

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 injectables, infusions, inhalants, eye drops, temperature-sensitive substances, anesthetics, emulsions, suspensions, and highly potent APIs.

Our BSL-2 certified BFS filling capabilities even enable us to fill biopharmaceuticals like vaccines and antibodies under strict safety measures, such as rigorous cleanroom protocols and specially trained staff.

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

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

Laboratory Testing

Comprehensive microbiological tests, stability storage and testing, chemical tests, and product analysis.

Container Design

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

Packaging Development

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.

Trial Filling

Compatibility Check through Trial Fillings

Every product has unique characteristics, and finding the optimal dosage form is crucial. Trial fillings allow you to assess the compatibility of your formula with BFS and identify the most suitable container design.

Once the primary and secondary packaging has been determined, we extensively test the end products to ensure they meet both functional and aesthetic requirements. Additionally, our trial fillings provide comprehensive documentation necessary for product approval.

GMP

Good Manufacturing Practice

Adhering strictly to Good Manufacturing Practice (GMP) guidelines, every product that leaves our facilities undergoes a thorough inspection. Our certified Blow-Fill-Seal (BFS) production process incorporates advanced inspection systems, including Vial Inspection Machines (VIM), High-Voltage Leak Detection (HVLD), and Cosmetic Inspection Machines (CIM). This ensures that you and your customers receive products of consistent and reliable quality.

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.

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