Product and process first
The client's production and quality teams define what matters, which contamination risks apply and which evidence is required.
Illustrative concept 04
Controlled production with protected continuity planning
A life-science, medical-device or precision-production company wants a defined production zone to resist selected disruptions, protect product quality, stop safely and recover under control.
- Host facility
- Small or medium production facility
- Illustrative protected scope
- Approximately 800 m² of controlled production and direct support space
- Example process
- Non-sterile production; exact product and process remain to be defined
- Operating objective
- Continue, hold safely, shut down or recover according to approved product rules
Client requirement
What the client needs.
- A clear product, process and protected-scope definition
- Controlled movement of people, materials, product and waste
- Verified critical utilities and failure responses
- Construction planning that protects ongoing operations
- Documented testing and quality acceptance before use
Decisions
What feasibility must establish.
- Which product, process and regulatory route apply?
- Does continuity mean operation, protected hold, safe shutdown or recovery?
- Which environmental parameters and utilities are critical to product quality?
- Which inspections, qualification and revalidation evidence are required?
Proposed concept
A practical protected scope, shaped by real needs.
Protected production boundary
Rooms, equipment, utilities, controls, data and storage are allocated according to their role in the selected process.
Controlled flows
Specialists coordinate people, material, product and waste movements to avoid unnecessary crossings and contamination risk.
Failure and recovery
Each critical service receives an approved continue, hold, shutdown or recovery response, followed by defined acceptance checks.
Deliverable
Feasibility Study / Initial Mandate
The mandate creates a decision-ready basis for specialist design and project delivery.
- Protected-scope and operating-requirements brief
- Process, room, equipment, utility and interface map
- Review of existing information and required investigations
- Concept and construction-phasing options
- Preliminary protected-scope construction budget and programme
- Specialist, procurement and contracting strategy
- Testing, documentation and operating-readiness plan
Initial Mandate / Feasibility Study
Starting fees
The final proposal reflects size, location, available information, specialist input, confidentiality requirements and required outputs.
| Feasibility Study / Initial Mandate | From CHF 50'000.- |
|---|
Scope note:
An ISO cleanroom class describes airborne-particle concentration; it does not by itself demonstrate sterility or pharmaceutical Good Manufacturing Practice. Product, process, jurisdiction, quality system and specialist verification determine the applicable requirements.
Evidence
Selected references
- ISO 14644-1:2015 — Classification of air cleanliness by particle concentrationInternational Organization for Standardization
- ISO 14644-4:2022 — Design, construction and start-upInternational Organization for Standardization
- EudraLex Volume 4 — Good Manufacturing PracticeEuropean Commission
- ICH Q9(R1) — Quality Risk ManagementInternational Council for Harmonisation