GMP-compliant Clean Rooms and Facilities

Background

A GMP-compliant pharmaceutical facility provides the structural and organisational framework for manufacturing high-quality medicines. Clean Rooms play a central role by ensuring controlled environments that minimise particulate and microbial contamination. Regulatory authorities define detailed requirements for design, operation and maintenance. Common compliance gaps include inadequate cleaning, insufficient control of personnel and material flows and incomplete documentation.

Many GMP problems originate already during the planning and construction phase. The design must anticipate regulatory expectations, future workflows, and technical interfaces – making project management a critical success factor. Cost, schedule, and GMP compliance must be balanced from concept to commissioning and qualification.

In addition to GMP, occupational safety is equally important in the planning and operation of manufacturing facilities. GMP and occupational safety have become closely linked with the introduction of the PDE/ADE concept, both aiming to prevent the release of active substances. While GMP focuses on avoiding cross contamination, Environment, Health & Safety ensures that employees are not exposed to harmful levels. Effective contamination control strategies therefore address both aspects.

Ensuring clean room and facility compliance requires a coordinated approach across engineering, quality, and production – with inspections and audits placing growing emphasis on risk-based thinking and data integrity.

This conference presents practical examples of how these requirements can be effectively implemented.

Case Study Boehringer Ingelheim: Super-Fast Track Design and Implementation of a new Pharma OSD Production Facility for two Blockbuster Drugs
Johannes Raethel, Glatt Ingenieurtechnik
Gerhard Hunger, Boehringer Ingelheim Pharma

Boehringer Ingelheim has extended its Pharma OSD capacity for two blockbuster drugs at its Ingelheim site in Germany with a new flexible OSD production facility, which was designed and built in a super-fast track project approach. The case study will provide an overview on the project development from early design phase, via engineering phases, fast track modular building construction, implementation of HVAC, cleanrooms, process equipment, handling and periphery systems, utilities, intralogistics and automation systems. Specific requirements to the super fast track schedule and related project execution strategies will be outlined.

• Design principles, plant structuring with process LLE packages
• Strategies for super-fast track project execution
• Layout modules and supply concepts for the new OSD facility
• Important success factors and challenges
  
  

Case Study Merck: A Use-Case from Merck Healthcare: Compressed Air Initiative
Fritz Röder, Merck Healthcare

Following the update of an ISPE Guide on Process Gases, Merck Healthcare has started an initiative to reassess all compressed air systems on all manufacturing sites worldwide (sterile and non-sterile sites). In the presentation will be shown:

• The results of the assessment
• The change of compressed air specifications and large energy savings that have been identified  

This study can serve as a use case for other pharmaceutical facilities that aim to further reduce their carbon footprint.

Project Faults and how to avoid them
Prof Dr Detlef Behrens, Technische Hochschule Mittelhessen (THM)

• Typical mistakes in pharma construction or upgrading projects
• Practical examples from various investment projects
• Do's and Dont's in Pharma Project Management
• Cost of Project Delays
  
  

Containment in a GMP Facility
Dr Andreas Flückiger, formerly F. Hoffmann-La Roche

• What is containment?
• Containment as a risk management measure in GMP and EHS
• Primary and secondary containment
• Selection of the right containment solution
  
  

Usage of Occupational Health Data for GMP Purposes?
Dr Andreas Flückiger, formerly F. Hoffmann-La Roche

• Containment for worker protection
• Measurement of containment ("SMEPAC")
• Air and surface sampling, air and surface limits
• Interpretation of the results in the EHS context
  
  

Cross-Contamination from the Perspective of a GMP Inspector
Dr Rainer Gnibl, Government of Upper Bavaria, Germany

• GMP inspector's expectations for avoiding cross-contamination (including organisational and technical measures
• How to decide: dedicated or shared facility?
• Annex I and the requirements for non-product-contact surfaces
• Cleaning validation and cross contamination
  
  

Case Study Novo Nordisk
André Campos Lourenço, Novo Nordisk  


Case Study Forschungszentrum Jülich: The Challenge of Manufacturing Radiopharmaceuticals in Accordance with EU Annex 1
Dr Philipp Krapf, Forschungszentrum Jülich  
Andreas Nuhn, D&B Pharma Design

• Contrary requirements GMP and radiation protection  
• Hygenic zone concept (pressure cascade, personnel and material flow)  
• Integration of hot-cells in a GMP clean room  
• Qualification concept
  
  

Case Study Ten23 health: Robot-assisted Pilot Line Sterile Filling
Dr Thomas Lemazurier, Ten23 health

• Scale-up
• Flexibility 
• Cost efficiency 
  
  

GMP-Compliant Sterile High Potency Manufacturing with Recirculated Air
Nikolaus Ferstl, Facility Engineering Services

Case study Chiesi Farmaceutici: Energy Saving and Decarbonization in a new Biopharma Manufacturing Facility
Alberto Ubertalli Ape, Chiesi Farmaceutici
Dr Pier Angelo Galligani, Techniconsult Firenze

• New pharmaceutical facility for the manufacturing of biological-based injectable products – a brown field project
• Commitment to sustainability, particularly focused on environmental protection and the prevention of climate change  
• Challenge to combine the sustainability issues with the GMP compliance in a critical aseptic manufacturing facility