Design
of your facilities
From preliminary requirements to the site master plan, we design GMP-compliant facilities built around your products, your flows and your inspections.
Standards EMA-Annex 1 · GMP · cGMP · ISO 14644 · ISPE · USP 797 · HACCP
Challenges we solve
Are you at one of these stages?
01
A new site to build
You’re starting from a vacant lot or an empty building, and the plant has to be compliant from its very first drawings.
Let’s talk about this challenge
02
An expansion or a new product
A new line, a new dosage form or more capacity, without disrupting current production.
Let’s talk about this challenge
03
Crossing flows
People, materials and waste cross paths, and the risk of cross-contamination worries your inspectors.
Let’s talk about this challenge
04
A license to obtain
Establishment license, cannabis license, DIN or NPN: the facility has to be compliant first.
Let’s talk about this challenge
A regulated facility is won or lost in its first drawings. We start from your needs and the regulations that apply, then define the site, processes, cleanrooms, utilities and storage, right down to protective equipment and gowning.
Every choice accounts for flows and cross-contamination risks, room and product integrity, and the licenses you need: establishment license, cannabis producer license, drug registration (DIN) and natural health product registration (NPN).
From plan to facility
Every facility starts with a plan.
The process, flows, utilities and cleanrooms are drawn and checked before the first weld.
Quality by design
Golden rule No. 1:
get the design
right from the start.
GMP compliance is far easier when facilities and equipment are designed and built right from the start. It is the first of the PIC/S ten golden rules.
45%of drug and device recalls stem from design problems
- 01Get the facility design right from the start
- 02Validate processes
- 03Write good procedures and follow them
- 04Identify who does what
- 05Keep good records
- 06Train and develop staff
- 07Practice good hygiene
- 08Maintain facilities and equipment
- 09Build quality into the whole product life cycle
- 10Perform regular audits
PPURS, a PBE Expert innovation
Requirements, from day one.
Preliminary user requirements (P-URS) set from the very start of the project, following guidelines our experts wrote across three categories and 100 regulatory criteria.
- More than twelve “P”s defined by PBE Expert
- Full compliance with GMP and EMA-Annex 1, built into every URS and into facility design
- P-URS and design for processes, clean utilities, HVAC, cleanrooms, fill-finish and facilities
- The goal: a final product that passes inspection
- PURS
- FURS
- VURS
What you get
Results you can show.
The site master plan and preliminary requirements (PURS)
The concept for processes, cleanrooms, utilities and storage
Personnel, material and waste flows
Selection of protective equipment and gowning
A design review and an impact assessment
Technical files for your licenses (DEL, DIN, NPN, cannabis)
Contamination control
Contamination control starts at the first drawing.
Flows, materials, barriers and cleaning: we design so that sterility does not rest on operators’ actions alone.
The EMA-Annex 1 methodWhat the service includes
The common core for every industry we serve.
Service sheet
Facility design
Page 1 of 1
- 01EMA-Annex 1 complianceContamination control strategy (CCS) built in from the first drawings
- 02Analysis of preliminary requirements (PURS), laws and regulations
- 03Site design, industrial master plans and Site Master File (SMF)
- 04Specifications for production skids, processes, layout, cleanrooms and classified areas
- 05Clean utility and pharmaceutical system specifications
- 06Specifications for storage areas, vaults, cold rooms and quality control (QC) laboratories
- 07Analysis of flows, contamination and cross-contamination (CCC) risks
- 08Preserving the integrity and asepsis of rooms, equipment and products
- 09Functional and technical program (PFT)
- 10Gowning and personal protective equipment (PPE)
Approved by
The PBE Expert team
By industry
Every industry adds its own requirements. Here is what comes on top of the common core, industry by industry.
Pharmaceutical3 items
- Technology transfer
- Personal protective equipment (PPE) and containment specifications
- Establishment and cannabis producer licenses, drug (DIN) and natural health product (NPN) registration
Biotechnology and vaccines4 items
- Specifications for clean utilities, clean systems and biological containment
- Personal protective equipment (PPE) and biological containment specifications
- Analysis of flows, contamination and cross-contamination (CCC) risks, and biosafety (BSL)
- Establishment licenses and drug registration (DIN)
EU-GMP therapeutic and medical cannabis11 items
- Selection of cannabis extraction and THC and CBD purification technologies
- Classification and specifications of cannabis-specific security systems (vault)
- Irrigation water and greenhouse air conditioning specifications
- Establishment and cannabis producer licenses, drug (DIN) and natural health product (NPN) registration
- Business plan, feasibility study and project management
- Cultivation site design, industrial master plans and Site Master File (SMF)
- UV bio-decontamination of cannabis plants, air and irrigation water
- Selection of cannabis drying and milling technologies, ATEX safety, energy efficiency
- Irrigation water, lighting, air conditioning and CO₂ specifications
- Specifications for compact indoor cannabis growing equipment
- Specifications for controlled environments and air conditioning in indoor growing (temperature, humidity, illuminance in lux)
Hospitals and pharmacies3 items
- Design of compounding areas for sterile injectables and highly potent, radioactive and allergenic products
- Specifications for production skids, processes, layout, cleanrooms and classified areas: USP 797
- Personal protective equipment (PPE) and containment specifications
Fine chemicals and APIs4 items
- Clean utility and clean system specifications
- Specifications for storage areas, cold rooms and quality control (QC) laboratories
- Protective equipment specifications
- Establishment licenses, drug (DIN) and natural health product (NPN) registration
Food11 items
- Analysis of preliminary requirements (PURS), laws and regulations: HACCP, SQF, ISO 22000, GFSI, ISO 9001
- Specifications for clean utilities, food drying and clean systems
- Specifications for ambient and refrigerated storage areas and quality control (QC) laboratories
- Flow and critical control point (CCP) hazard analysis, functional and technical program (PFT)
- Maintaining sanitation and hygiene in production rooms, equipment and products
- Process optimization, lower operating (OPEX) and capital (CAPEX) costs
- Treatment and neutralization of gaseous, liquid and solid effluents
- Support with environmental certificate of authorization (CA) applications
- Selection and layout of manufacturing equipment and systems
- Clean-in-place (CIP) and sanitization system specifications, procedure compliance
- Flow and hazard analysis (HACCP), functional and technical program (PFT)
In practice
One project as an example.
Frequently asked questions
What people ask us.
Do you start from a blank page or an existing building?
Both. We design new sites and convert existing buildings, keeping current production in mind.
Which standards do you apply?
GMP and cGMP, ISO 14644, ISPE guides, USP 797 for sterile compounding and HACCP for food.
Can you also build and validate the facility?
Yes. We run turnkey projects (EPCMV), from design to validation, with a single point of contact.
Let’s talk about your project.
A new site, an expansion, an inspection to prepare for: describe your project and one of our experts will get back to you.