Sterile Fill / Finish.

Your trusted partner in aseptic processing

With extensive experience in sterile fill finish development and manufacturing, our team can support you with aseptic and terminally sterilized small volume liquids and powders for parenteral, nasal and pulmonary delivery.

Sterile Fill/finish for biologics and small molecules

Sterile manufacturing facility.

A purpose-built 7,000 sq ft facility, designed specifically in line with the revised EU GMP Annex-1 regulations, enables the development, manufacture, testing and fill/finish of sterile drug products for biologics and small molecules.

Alongside existing full-service formulation development and quality control laboratories, our team can support your drug development with expertise and speed.

Aseptic Processing 3 Chamber Isolator

Sterile Fill/finish for biologics and small molecules

Isolator filling line.

  • Grade A isolator environments within Grade C cleanroom suites
  • Three-chamber solid wall VHP isolator
  • Up to 2,000 units for 2R, 10R and 20R vials (pre-filled syringes – future capability)
  • 100% In-line weight checks
  • 0.25ml up to 20ml dosing ranges
  • Complex aseptic processes
  • Vapor-phase hydrogen peroxide
    decontamination cycles developed
  • Automated crimping process in Chamber 3
  • PUPSIT Integration (Pre-Use-Post-Sterility-Integrity-Testing)
Aseptic Processing 3 Chamber Isolator

Sterile Fill/finish for biologics and small molecules

Contamination Control Strategy at the heart of facility design.

  • Solid-wall VHP three chamber isolator (Envair Technology) providing automated bio decontamination cycles, flexible processing and filling, and extended sterility assurance levels
  • Dry heat depyrogenation (LAST Technology) for high-temperature sterilisation
  • Aseptic liquid filling capability (Flexicon) with configurable fill-finish tooling
  • Independent HVAC supply and return systems with real-time differential pressure, temperature, humidity, and particle monitoring
  • Pre-Use Post Sterilisation Integrity Testing (PUPSIT) has been incorporated to comply with Annex 1, ensuring verification of sterilising-grade filter integrity before and after processing
  • Integrated viable and non-viable environmental monitoring system, including continuous airborne particle counting
  • Terminal moist-heat sterilisation (LTE Scientific autoclave) for sealed product sterilisation
  • Container closure integrity testing meeting Annex-1 requirements via vacuum technology – SEPHA
Aseptic Processing 3 Chamber Isolator

Accelerate your sterile drug development with Upperton's expertise and state-of-the-art facility

Vials and prefilled syringe fill-finish capability

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Aseptic Processing

Sterile fill/finish services for parenteral drug products.

Our contract manufacturing capabilities and successful regulatory history support you in maximising the success of your drug product.

Our sterile processing capabilities include:

Sterile drug products – aseptically prepared.

Liquid formulations and powders for parenteral, nasal and pulmonary delivery.

– Wide range of molecules from small molecules to biologics (including proteins, peptides and mAbs).

Aseptically prepared spray-dried powders.

Integrated CDMO services

Sterile fill / finish expertise you can trust

Our Leadership Team excels in steering products from pre-clinical to market. This extensive expertise forms the cornerstone of our service to you, ensuring hands-on involvement at every stage and every level of our business.

Alongside our upcoming aseptic capabilities, our formulation development across a broad range of dosage forms, clinical trial supply, and niche-scale commercial manufacturing for non-sterile dosage forms provides accessible scale-up and unparalleled project delivery.

Analytical and QC Testing

From environmental monitoring to final product testing,
our dedicated 8,000 sq. ft Quality Control and Analytical laboratories provide:

  • Endotoxin testing
  • HPLC
  • Sub-visible particles
  • Bioburden
  • Osmolality
  • pH and stability testing
  • QP Release
  • Outsourced microbiological testing partners

Aseptic sterile processing.

Our Grade C processing room features an Envair CIVAS Positive Pressure Solid Wall Processing Isolator, alongside…

  • Class III biological safety cabinet
  • LAST Dry Heat steriliser depyrogenation oven
  • LTE 435 litre pass-through Autoclave
  • 3P Innovation Vial Rotary Crimper
  • Flexicon Peristaltic Aseptic Liquid Filling Machine

360° image – drag to move around

Want to find out more about our sterile processing capability?

Download our brochure to learn more about our sterile fill / finish capability.

Frequently Asked Questions

Sterile fill-finish is the final step in the drug manufacturing process for injectable medications and other parenteral products. It involves filling the drug product into its final containers (such as vials, syringes, or cartridges) under strictly controlled aseptic conditions to ensure sterility.

  • Formulation development and stability testing
  • Aseptic preparation and terminally sterilized products
  • Batch sizes up to 2,000 units
  • Filling of vials and pre-filled syringes
  • CMC sterility assurance package

Infosheet

Aseptic Processing Services

Production area

  • Production Area
  • 2 purpose-designed processing rooms
  • VHP solid wall processing isolators
  • Dedicated isolators for spray drying (future capability)
  • Depyrogenation ovens and autoclaves
  • Visual inspection room
  • Formulation development and stability testing
  • Aseptic preparation
  • Batch sizes up to 2,000 units
  • Filling of vials
  • CMC sterility assurance package
  • 7,000 sq ft. purpose built GMP sterile manufacturing facility
  • Designed specifically in line with the revised (August 2023) EU GMP Annex-1 regulations
  • Advanced VHP isolator barrier technology

Why choose Upperton?

One team, from start to finish.

We keep the knowledge of your molecule within the same project team, ensuring continuity and access to subject matter expertise across all layers of our business.

One site, for seamless scale up

We keep the knowledge of your molecule within the same project team, ensuring continuity and access to subject matter expertise across all layers of our business.

Award-winning facility

We keep the knowledge of your molecule within the same project team, ensuring continuity and access to subject matter expertise across all layers of our business.

One team, from start to finish.

We keep the knowledge of your molecule within the same project team, ensuring continuity and access to subject matter expertise across all layers of our business.

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Let's Talk.

Book a discovery call.

Speak with our team of experts and set up a discovery call to discuss your project in more detail.