Blow Fill Seal Technology

Blow fill seal technology forms, fills, and seals a plastic container in one automated, enclosed cycle that limits human intervention and reduces contamination risk. The polymer is extruded into a tube, blown into a mold, filled with sterile product, then sealed—usually within seconds. This closed design is why regulators treat BFS as an advanced aseptic approach. You’ll see it most where sterility and speed matter. It also simplifies plants because one machine replaces multiple steps.

Common uses include ophthalmic unit doses, respiratory and inhalation solutions, sterile saline and IV fluids; many firms also run nutraceutical and diagnostic liquids. B-F-S is attractive for unit-dose formats because containers are light and shatter-resistant. It scales from small ampoules to large-volume bottles without switching to glass. Adoption continues to rise as companies prioritize sterility and throughput.

Yes. FDA guidance describes B-F-S as an automated aseptic process and applies the same sterile drug standards to it as other aseptic methods. In Europe, Annex 1 sets detailed expectations for B-F-S within sterile manufacturing, reinforcing contamination control and integrity testing. When you design your controls around these texts, inspections go smoother.

LDPE is common for squeezable, single-dose ophthalmic and respiratory packs; PP is selected when higher heat resistance or stiffness is needed. For better barrier, some designs add EVOH or similar layers to reduce oxygen ingress or aroma transfer. Material choice balances drug compatibility, permeability and user feel. Early extractables and leachables studies are essential.

The mold must be hot enough to form the container but filling happens immediately after forming and can be engineered to keep product exposure brief. Suppliers tune parison temps, cooling and dwell times so liquids return to near room temperature quickly. For sensitive biologics, “cold” B_F_S variants and parameter optimization further limit thermal load. Always verify with stability and CQAs.

It’s feasible with the right controls. Industry case studies and CDMO experience show B_F_S handling of some biologics and vaccine presentations, provided heat, oxygen, and moisture are tightly managed. Pay attention to formulation, barrier needs, and real-time monitoring, then confirm via stability and integrity data. Not every molecule is a fit, so perform risk-based trials.

Annex 1 emphasizes contamination control strategy across the line and adds a clear expectation for 100% integrity testing on containers closed by fusion, which includes B-F_S ampoules and bottles. Visual inspection alone is no longer enough for these closures. Plan deterministic integrity checks in-line or at release and document the method’s sensitivity.

Deterministic methods like high voltage leak detection and vacuum decay are widely used for liquid filled B-F-S. Helium mass-spectrometry offers ultra high sensitivity for special cases, while headspace analysis can support oxygen control. Current best practice favors deterministic, quantitative tests over legacy dye ingress whenever possible. Validate sensitivity to your product’s MALL.

Follow FDA aseptic guidance: qualify equipment, perform media fills that reflect real interventions, and prove your cleaning and sterilization steps. Map alarms and holds to a risk-based control strategy and show container-closure integrity per Annex 1. Keep robust environmental monitoring, then trend results to demonstrate a sustained state of control.

CIP validates cleaning of product-contact surfaces, while SIP or equivalent sterilization readies the path before filling. In the sterile zone, firms often use steam or hot water on filling hardware and hydrogen peroxide for adjacent forming areas—within a controlled “tunnel” or enclosure. The goal is commercial sterility at startup and consistency during runs.

From unit-dose twist-offs and ampoules to multi-dose bottles and infusion containers, BFS molds many shapes and volumes. The process is flexible enough to add features like droppers or connectors right in the mold. Container strength and shatter resistance help in shipping and cold chain. Choose geometry by dose accuracy and user handling tests.

Because forming, filling and sealing are integrated BFS reduces manual touchpoints and related contamination paths. It can also boost uptime and cut floorspace versus separate forming and filling rooms. On the other hand, you must manage polymer permeability and potential thermal exposure. A fit-for-purpose risk assessment decides the winner per product.

There is growing demand for ophthalmic and inhalation formats as well as lightweight, nonbreakable packs for logistics. Sustainability is driving lighter-weight compacting and optimized energy in molding. Annex 1st integrity trend is further driving the adoption of in-line CCIT, CDMOs are expanding their BFS capabilities to facilitate technology transfer and accelerate upgrades of BFS technology from development to production.

Watch for product polymer compatibility especially oxygen or moisture sensitivity that might be require barrier layers, control heat exposure during forming and verify no negative impact on potency for proteins and vaccines. Build deterministic CCIT early to avoid revalidation later. User testing should confirm opening torque and dose accuracy.

Write a tight user requirements spec audit vendors for mold and CCIT expertise and prototype container geometry early. Align media fills with real interventions, validate CIP/SIP and connect MES or eBR for data integrity. Choose a deterministic leak test to meet Annex 1, Finish with stability, E&L and usability before PPQ.