Clean Room Setup

Clean room setup involves designing and implementing controlled environments that protect products from particle and microbiological contamination in the production of pharmaceuticals, cosmetics, dietary supplements, and medical devices. Envora Global approaches clean rooms not just as a standalone panel application but considers them in conjunction with material and personnel flow, HVAC, industrial water, and quality systems.

What Do We Cover in Clean Room Setup?

• GMP layout plan: classification of production, weighing, filling, packaging, and auxiliary areas; unidirectional material and personnel flow.
• HVAC – clean room ventilation systems: design of pressure levels, filtration, and air conditioning systems along with building automation (BMS).
• Clean room partition and panel systems: hygienic design and implementation of wall, ceiling, door, and window details.
• Industrial water systems: integration of DI (deionized) water and WFI systems when necessary.
• Qualification and validation: documentation that the installation meets design requirements and commissioning.

For Which Industries Do We Set Up Clean Rooms?

Our references include areas for human and veterinary medicines, traditional herbal products, cosmetics, dietary supplements, biocidal products, and Class I–II medical device production. Quality control, microbiology, and R&D laboratories are also significant components of the projects.

Each sector’s needs are different: in pharmaceutical facilities, EU-GMP and FDA expectations when necessary, in cosmetics GMP, in dietary supplements GMP/HACCP, and in medical devices ISO 13485 quality systems are determinants. We shape clean room design according to these requirements.

New Facility or Transformation of Existing Space?

Clean room setup can be carried out in a newly constructed facility or through the adaptation of an existing building to GMP standards. The renovation of HVAC systems and EU-GMP applications at Sandoz Pharmaceuticals’ Levent and Bakırköy factories serves as an example of transforming existing facilities; Novartis Pharmaceuticals Kurtköy and VEM Pharmaceuticals Çerkezköy are examples of new facility projects.

Common Mistakes in Clean Room Setup

The most frequent issues encountered in clean room projects stem from not clearly defining user requirements during the design phase. Panel and ventilation investments made without determining product groups, production forms, and target standards can lead to costly revisions later on. Layouts where material and personnel flows intersect, inadequate pressure levels, hard-to-clean details, and postponing validation until the end of the project also increase the risk of findings during inspections.

Therefore, we start clean room setup with concept design; we redefine the class of each area, pressure relationships, and usage scenarios from the outset. We aim to deliver the facility ready for inspection by considering qualification and validation requirements from day one of the design.

Why Envora Global?

Envora Global integrates its engineering experience in mechanical installation and hygienic production spaces with GMP and quality system requirements. A single project team coordinates the design, implementation, qualification, and training processes. This approach reduces interface problems between different suppliers and consolidates responsibility in one location. Throughout the project, we monitor target standards, budget, and schedule together with you.

Laboratories and Support Areas

Clean room projects typically include quality control, microbiology, and R&D laboratories. Laboratories in COSMED, TALYA Herbal, and ELIT Pharma projects have been planned alongside production areas. The location, ventilation, and material flow of the laboratories are designed to be compatible with the production areas.

All project design and implementations are carried out in compliance with GMP (Good Manufacturing Practices) regulations, ISO and HACCP standards, as well as the requirements of the Ministry of Health / Ministry of Agriculture and Forestry.

Our Process in Clean Room Projects

1. Concept Design: defining product groups, capacity targets, material and personnel flows.
2. Project Planning: GMP layout plan, HVAC – clean room, DI water, and other infrastructure systems design.
3. Installation and Implementation: clean room partition and panel systems, selection and installation of production machines.
4. Qualification and Validation: verification of equipment, systems, and processes, commissioning.
5. Quality System and Preparation for Inspection: documentation, training of key personnel, and preparation for official inspections.

Our Reference Projects

• Mamsel Pharmaceuticals Production Facility Project – Mamsel Pharmaceuticals, Istanbul / Tuzla (2014–2015): human medicine, cosmetics, and biocidal production areas; concept design and redesign.
• ELIT Cosmetics Production Facility – ELIT Cosmetics, Istanbul (2018): cosmetics production facility concept design and implementation; GMP training and documentation.
• COSMED Cosmetics Production and R&D Center – COSMED, Istanbul (2024–2025): cosmetics production and R&D center; project design, implementation, training, and documentation.
• MEDFORS FARMA Medical Device and Dietary Supplement Facility – MEDFORS FARMA, Istanbul (2026): turnkey project; medical device and dietary supplement production areas.
• Sandoz Pharmaceuticals Levent Factory Renovation Project – Sandoz Pharmaceuticals, Istanbul / Levent (1989–1996): HVAC ventilation and air conditioning system; EU-GMP applications and factory renovation.
• Novartis Pharmaceuticals Kurtköy New Production Facility – Novartis Pharmaceuticals, Istanbul / Kurtköy (2001–2004): new production facility concept design; unidirectional process flow and lean production.

Let’s Plan Your Project Together

To evaluate your needs for your clean room project and to create your roadmap together, contact Envora Global.