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ALVEDA SOLUTIONS

Solution 02 / 07

Sterile & Aseptic Facility

In sterile manufacturing the facility is part of the contamination barrier. ALVEDA SOLUTIONS engineers the rooms, air, water and sterilisation interfaces as one contamination control system, designed with consideration for the sterile requirements applicable to the project.

Discuss your facilitySee the engineering path
Cleanroom production suite with a stainless-steel process skid, ceiling air diffusers and gowned operators in the background

The problem and its context

Sterile products leave little room for correction after construction. Grade relationships, airlock sequences, transfer routes and the position of the critical zone are difficult to change once walls, ducts and utilities are installed.

Where the project basis includes the EU GMP Annex 1 approach, a documented contamination control strategy (CCS) is expected to tie the facility, utilities, process, people and monitoring together. Engineering decisions should feed that strategy from the start rather than being described in it afterwards.

Typical pressure points

  • Defining the critical zone and the barrier technology early enough to shape the layout
  • Airlock and gowning sequences that are practical for operators as well as compliant
  • Pressure cascades that stay stable when doors open and filters load
  • Sterilisation, transfer and water interfaces designed as part of the cleanroom, not around it

What the solution involves

  1. 01

    Facility zoning around the critical zone, with grade transitions and transfer routes

  2. 02

    Cleanroom envelope, finishes and details suitable for repeated cleaning and disinfection

  3. 03

    HVAC and pressure cascade design with unidirectional airflow where the process requires it

  4. 04

    Engineering inputs to the contamination control strategy: facility, utilities, flows and monitoring

  5. 05

    Integration of sterilisers, depyrogenation and transfer systems into the layout

  6. 06

    Environmental monitoring locations and a qualification approach for the classified areas

Engineering path

The service disciplines involved, in the order the project needs them. Each step links to the full service description.

  1. 01Sterile and aseptic facility engineeringThe overall sterile concept: process, barrier approach and critical zone.
  2. 02Grade zoning and aseptic flow planningGrade transitions, gowning sequences and material transfer routes.
  3. 03Cleanroom design for classified areasEnvelope, finishes, doors, pass-throughs and cleanable details.
  4. 04Pressure cascade and airflow designPressure relationships between grades, tuned to the selected basis and process risk.
  5. 05HVAC for sterile and aseptic areasAir handling, terminal filtration, recovery and control strategy.
  6. 06WFI and clean steam systemsWater and steam grades required by the products and the pharmacopoeia applied.
  7. 07Sterilisation and aseptic process supportSteriliser, depyrogenation and transfer interfaces placed in the layout.
  8. 08Environmental monitoring designSampling locations, monitoring approach and data inputs to the CCS.
  9. 09GMP review and contamination control strategy inputsDesign decisions recorded so they can be referenced in the CCS.
  10. 10Cleanroom and utility qualificationQualification of classified areas, HVAC and water against the design basis.

Deliverables and design basis

Typical deliverables

  • Sterile concept and critical-zone definition
  • Grade zoning, gowning and transfer flow drawings
  • Pressure cascade and airflow diagrams for the agreed basis
  • Room data sheets for classified areas
  • HVAC, WFI and clean steam design packages
  • Engineering inputs to the contamination control strategy
  • Environmental monitoring location plan
  • Qualification plan for classified areas and utilities

Key design-basis considerations

  • Aseptic processing or terminal sterilisation route
  • Barrier approach: isolator, RABS or conventional open processing
  • Cleanroom grades and the regulatory basis agreed for the project
  • Product, container and closure handling steps
  • Operator numbers, gowning practice and shift pattern

Classification, pressure relationships and containment are set by the project regulatory basis and the process risk.

How the regulatory design basis is set

The contamination control strategy belongs to the manufacturer’s quality system. ALVEDA SOLUTIONS provides the engineering inputs and design rationale it draws on.

Related sectors

Next step

Planning this type of facility?

Share the product, the capacity and where the project stands. An engineer will reply with a proposed engineering path.

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