Eramol, a UK-based pharmaceutical contract development and manufacturing organisation (CDMO), has made significant progress on its new sterile manufacturing facility in Sevenoaks, Kent.
Scheduled to open in early 2026, the 11,000 sqft site is purpose-built to support the small to medium batch production of sterile injectable products and aligns with the stringent standards of EU GMP Annex 1 (2023).
The facility includes a dedicated 1,900 sqft GMP Grade A/C cleanroom suite, supported by modern office space and client reception areas, creating a fully integrated and client-ready environment.
Eramol told Cleanroom Technology that T-Squared was the contractor for the facility, utilities, BMS, and EMS services; Steritech/Fedegari were used for the autoclave (terminal sterilisation) and 3P and IWT were used for isolator and filling technologies (aseptic).
Eramol also revealed some exclusive insights to Cleanroom Technology regarding the facility's contamination control strategy, equipment specification, HVAC design, and digital technologies being deployed on site.
Scheduled to open in early 2026, the 11,000 sqft site is purpose-built to support the small to medium batch production of sterile injectable products
Eramol shared details about the contamination control measures, isolator automation and energy-efficient HVAC systems underpinning the new facility.
David Cox, Site Director at Eramol said: “Contamination control has been placed at the heart of the facility’s design and equipment selection, in line with both the requirements and spirit of Annex 1.”
Cox explained that given the inherent unknown risks associated with Investigational Medicinal Product (IMP) processing, the site employs single-use processing technologies and controlled airflow strategies to protect both the product and personnel. Localised processing booths within Grade C areas utilise H14 HEPA filtration as standard to prevent cross-contamination during open product handling.
Cox added that the isolator is fully HMI-driven for decontamination and aseptic operation, dynamically monitoring the environment to ensure Grade A conditions.
The HVAC system has been engineered for precision contamination control. It uses direct-drive VSD fans to independently manage air supply and extraction, dynamically maintaining pressure cascades in Grade C/D (ISO 7 / ISO 8) rooms.
Grade C processing areas and the Grade A isolator operate on a total extract system, minimising cross-contamination
The system is managed by an advanced Building Management System (BMS), which enables energy efficiency by reducing fan speeds outside of operational hours.
The building’s airflow design ensures that air inlets and exhausts are positioned on opposite sides, considering prevailing wind direction to prevent exhaust air from re-entering the facility.
Grade C processing areas and the Grade A isolator operate on a total extract system, minimising cross-contamination between material processing areas. Grade D and CNC spaces adopt a recirculation approach to reduce energy consumption.
The HVAC system has been engineered for precision contamination control
The facility will house advanced equipment, including a Fedegari autoclave for terminal sterilisation and a high-performance aseptic isolator system from 3P and IWT, which allows aseptic filling of sterile solutions into 2ml and 10ml vials.
The isolator is fully HMI-driven and capable of dynamically monitoring and maintaining Grade A conditions during decontamination and aseptic operations. Data is synchronised with the environmental monitoring system (EMS) via Modbus.
Other technical features include:
- Active environmental monitoring for both the facility and isolator
- Load cell technology for all filling operations
- Force monitoring during vial crimping
- Pressure/vacuum decay testing for container closure integrity
- In-process monitoring and defined process controls for repeatability and scale-up
- Technologies and workflows optimised to minimise waste and support transition to commercial manufacture
The isolator installation is scheduled for October 2025, with commissioning and qualification, such as autoclave cycle development and performance validation, beginning in September.
The isolator installation is scheduled for October 2025
An MHRA inspection is expected by the end of 2025, paving the way for client onboarding soon after.
Peter Mollison, Co-CEO and Co-Founder at Eramol, said: “This facility reflects our commitment to supporting clients with a flexible, compliant, and forward-thinking approach to sterile manufacturing.
“We’ve built-in expansion capacity and the agility to scale with our partners to develop long term strategic collaborations.”
Eramol’s cleanroom project was delivered with support from a number of specialist contractors, including T Squared for the facility, utilities, BMS, and EMS services; Steritech and Fedegari for the autoclave; and 3P and IWT for the aseptic isolator and filling technologies.
[QUOTE] The new site is tailored to meet the needs of biotech, pharma, NHS, academia and virtual pharma clients looking for UK-based CDMO capabilities
The new site is tailored to meet the needs of biotech, pharma, NHS, academia, and virtual pharma clients looking for UK-based CDMO capabilities, offering:
- Aseptic filling and terminal sterilisation
- Small to medium clinical batch manufacturing
- End-to-end pharmaceutical services, including QP release, storage, and global distribution
“Our sterile offering focuses on small-scale manufacturing, ensuring product containment, yield maximisation, and scalable processes,” added Mollison. “Beyond sterile manufacturing, we also provide full downstream packaging, worldwide storage and distribution, and comprehensive QA/QP services, supporting clients at every step of their development journey.”