What is BFS

How BFS Works – In 3 Seconds

B

Blow

Sterile polymer resin extruded into a mold to form the container.

F

Fill

The container is filled with the sterile product immediately.

S

Seal

The container is hermetically sealed – no exposure, no risk.

Benefits

Key BFS Advantages for Pharma Manufacturers

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Minimal Contamination Risk

In the enclosed BFS process, container molding, filling, and sealing occur in one automated step — unlike traditional multi-step methods with separate washing, sterilizing, and capping. This eliminates environmental exposure and human contact, making BFS recognized as an advanced aseptic process.

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Proven & Compliant

Backed by 60+ years of pharmaceutical expertise, our bottelpack machines meet the industry’s strictest standards, including EU GMP Annex 1, and comply with regulations from EMA, FDA, Anvisa, and more.

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Strategic Economic Value

Our compact filling machines cut capital costs by eliminating the need for washing, sterilizing, and capping equipment and by reducing cleanroom space. Operational costs stay low thanks to low energy use, minimal maintenance, lean staffing, and cost-efficient polymer granulate.

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Resilient & Simplified Supply Chain

Produce primary packaging directly at the point of fill from medical-grade polymer resin – eliminating components such as vials, stoppers, and caps, while reducing supplier, transport, and storage needs.

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Protection for Sensitive Products

Our enclosed BFS process enables safe filling of heat-sensitive products like biologics and vaccines without terminal sterilization. For extremely heat-sensitive products, our innovative coolBFS technology further minimizes heat exposure.

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Flexible Container Design

Our BFS technology, offers unparalleled flexibility, enabling single-dose, multi-dose, and specialized container designs like Luer-Lock systems to meet diverse pharmaceutical applications.

Pharma applications

Applications of Our Pharmaceutical Filling Machines

  • Rendering of BFS ampoules for eye drops with label
  • Rendering of BFS ampoules for eye drops
  • Rendering of a single BFS ampoule for eye drops
  • Multi-dose ampoule for eye drops with label
  • Multi-dose ampoule for eye drops with label

Ophthalmics

Sterile Blow-Fill-Seal ampoules made of high-quality, recyclable low-density polyethylene (LDPE) are the ideal primary packaging for ophthalmic products, suitable for both single and multiple use. They meet the highest standards in user-friendly handling, format flexibility, product protection, and comply with regulatory requirements such as USP <771>.

Unit-Dose (Typically 0.1-1ml)

  • Up to 33,300 ampoules per hour
  • Preservative-free
  • Easy-to-open twist-off cap
  • Easy to dispense

Multi-Dose (Typically 1-15ml)

  • Up to 12,000 ampoules per hour
  • With or without preservatives
  • Closable, tamper-proof closure
  • BFS ampoules for injection solutions with label
  • BFS ampoules for injection solutions with calibrated luer system
  • BFS ampoules for injection solutions with ventilated luer system

Injections

Our recyclable LDPE or polypropylene (PP) ampoules are engineered explicitly for small-volume injectables ranging from 1 to 20 ml. They enable filling even demanding pharmaceutical products with sensitivities to heat, light, or oxygen and fulfill regulatory requirements such as USP <790> and <1790>.

  • Up to 33,300 vented or 20,000 calibrated ampoules per hour
  • Luer connection for easy and safe use
  • Calibrated Luer ampoules collapse during the withdrawal process with the syringe, preventing air ingress and contamination.
  • Terminally sterilizable
  • BFS bottle for infusion solutions
  • BFS bottle for infusion solutions with nipplehead closure
  • Various caps on bottles
  • Bottle for infusion solutions

Infusions

The unbreakable, lightweight, and terminally sterilizable BFS infusion bottles are the superior packaging choice for infusion products. They can be vented or unvented and feature an integrated suspension device for versatile use.

  • Up to 10,000 bottles per hour
  • Various container geometries in the 50-1000 ml range
  • Optimized for effective product withdrawal even without ventilation due to the collapsing design of the infusion bottle
  • Product withdrawal through caps with an infusion port (Euro head) or nipple head.
  • Inhalation solution BFS Ampoules with twist-off caps
  • Small round BFS ampoules for inhalation solutions
  • Two BFS ampoules for inhalation solution device
  • single bfs ampoule for inhalation solutions

Inhalation Solutions

Pharmaceutical products used in inhalers or nebulizers are safely protected in sterile BFS ampoules. With a user-friendly twist-off cap and soft LDPE material, our ampoules provide safe, convenient dosing for patients. Whether you need single doses starting at 0,25 ml or closable multi-doses up to 5 ml, we’ve got you covered.

  • Up to 33,300 ampoules per hour
  • Single or Multi-Dose
  • Flexible in geometry, e.g. ampoules can be directly inserted into inhalation devices

The Perfect Pharmaceutical Filling Machine for a Wide Range of Products

Rommelag’s machines are ideal if:

  • Your filling volume ranges from 0.1ml to 1000 ml
  • You want to fill sensitive pharmaceutical products
  • You need sterile single- or multi-dose products
  • You want to rely on proven container designs
  • You require vented or unvented containers
  • Custom forms and functions are necessary for your product
  • Your formulation must be free from preservatives

BFS Adoption Paths

Your Pharmaceutical Filling Solution — Three Proven Paths

Backed by over 70 years of BFS innovation and trusted by leading pharmaceutical companies worldwide, we offer three proven paths to achieve your production and market goals.

 

1 - Own a Machine

Invest in your own Rommelag bottelpack BFS machine for maximum control, output rates up to 33,000 units/hour, the lowest possible cost per unit, and format changes in under two hours.


2 - Leverage Our Pharma CDMO Services

Access our high-output BFS lines, GMP-certified facilities, and expert operators without upfront equipment investment — ideal for accelerating market entry, managing production peaks, or testing new formulations.


3 - The Hybrid Path

Start lean with our CDMO services. Once your product proves successful, transition seamlessly to in-house BFS production with full technology transfer, training, and process validation — ensuring a smooth, low-risk scale-up.

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Let’s Build Your BFS Advantage

Discover how our BFS technology can make your pharma packaging safer, simpler, and more cost-effective.

In a complimentary strategy session, our experts will work with you to:

  • Tailor the optimal BFS solution to your product's unique requirements.
  • Ensure compliance with EU GMP Annex 1, FDA, EMA, and other global standards.
  • Identify the best adoption path — turnkey machine ownership, CDMO, or the hybrid model
  • Calculate your long-term ROI and Total Cost of Ownership (TCO) to demonstrate the clear economic advantages of BFS.