Catalogue of turnkey services of COMSA Cleanroom Technology

1. PHARMACEUTICAL INDUSTRY
AND BIOTECHNOLOGY

2. BIO & PHARMA
A leader company in global projects
including engineering, civil construction,
critical installations and maintenance for the
pharmaceutical industry.
OUR CUSTOMER, OUR PRIORITY
Our capacity and flexibility allow us to tailor our
offer to your needs.
EXPERIENCE, EXCELLENCE,
PROFESSIONALISM
The high degree of specialisation of our
engineers and technicians is our guarantee of
excellence for the success of your project.
COMMITMENT TO INNOVATION
We are pioneers in promoting new technologies
and are committed to the constant pursuit of
innovation.
EXPERTS WITHIN A LARGE
GROUP
COMSA Cleanroom Technology gives you the
guarantee of its experience with the support of
the COMSA Corporación group.
More than
60 years
of experience
More than
400
references
Since
1953*
*Previously Luwa
Presence in
Europe, Latin America
and North Africa

3. 03
01
02
PHARMACEUTICAL INDUSTRY
AND BIOTECHNOLOGY
With more than 60 years of experience as partners of the
pharmaceutical industry, we propose turnkey solutions to
conceive, construct, certify and validate your production
installations through our Bio & Pharma projects.
With the aim of offering comprehensive management
to our clients, we take charge of the whole process
necessary to carry out each and every stage of a project
with these characteristics. To this end, our services include
consultation for the purposes of the preliminary project
on the space where the installation is going to be built, as
well as detailed engineering, execution and management
of the civil works, which includes the development of the
surrounding area and the construction of the infrastructure,
as well as the installations and their commissioning.
Wealsointerveneinthepharmaceutical,API,biotechnology,
veterinary, cosmetics and healthcare sectors, using
innovative applications that allow our clients to advance
in the manufacture of safer, quality products, responding
to the latest requirements in terms of Good Manufacturing
Practices (GMP), complying with standards and respecting
the environment.
01 Pharmaceutical industry production area
02 Pharmaceutical industry solid forms
03 Fine chemicals industry & APIs

4. 01
02
03
04
OUR SERVICES
CUSTOMISED SERVICES
• Conceptual and basic design
• Galenic process development
• Execution of civil works projects
• Construction of pharmaceutical installations
• Start-up and commissioning
• Qualification and validation
• After-sales service and Maintenance
• Specific training
01 Specialist in commissioning
02 Resources planning
03 Project management
04 ISO5 laminar flow qualification
A
CUSTOMISED
SERVICE
BASIC
CONCEPTION
MASTER PLAN - VMP
START-UP
COMMISSIONING
DETAILED
ENGINEERING
CONSULTING
CONSTRUCTION
AND
INSTALLATION
QUALIFICATION
VALIDATION
AFTER-SALES SERVICE
GMP ADVICE
QUALITY SYSTEM

5. COMMISSIONING
& VALIDATION
Engineering expertise
at the service of qualification
We provide our customers with solutions to integrate
and merge engineering knowledge and qualification
processes. This methodology allows the optimisation of
efforts, costs and qualification and validation deadlines.
The critical phases of qualification occur during the
starting up (commissioning) stages and not afterwards.
Our experts also advise you in the definition and
implementation of:
• VMP: Verification Master Plan
• Impact Analysis
• Risk Analysis
• Design Qualification DQ
• Validation and Qualification Policy
• Maintenance Plan
• Standardised Procedures
• Standard Protocols of IQ OQ
• Performance Qualification Protocols
• Calibrations
• Validation of Control Systems, IT Systems (GxP – GAMP)
Process Design &
Conceptual
Master Plan
Detailed engineering &
Consulting
Engineering &
Procurement
Construction
Commissioning
Production
Master Plan
URS - DQ - DR - Risk Analysis
VMP
Supervision of Suppliers
FAT - SAT - Implementation Supervision
- Metrology
Drafting Implementation IQ - OQ - PQ
Validation - PQ
Planning
Cost Control
Training
PHARMA ENGINEERING PHARMA VALIDATION
Regulatory Compliance
COMSA
BIO & PHARMA

6. 01
02
CIVIL WORKS AND BUILDING
Execution of turnkey projects in which the client is offered the
integrated management and construction of the infrastructu-
re dedicated to the Bio & Pharma sector through all its sta-
ges from the very beginning: Preliminary Project Consultation,
Detailed Engineering, Execution and Management of the civil
works, including the development of the surrounding area and
the construction of the infrastructure, as well as the installa-
tions and their commissioning.
ENVIRONMENT
Modular system of cleanrooms
Complete construction of clean rooms including enclosures,
lighting systems, electricity, transfer solutions, SAS, air showers,
control and monitoring systems, etc.
Air treatment for critical areas
Control and regulation of temperature and humidity.
Sterility and containment by means of filtration solutions and
decontamination of air, including primary barriers (weighing
and sampling booths) and isolators.
Closed system designs.
OUR PROPOSAL
01 Upstream area detail
02 Biopharmaceutical industry enclosures

7. 01
02
CRITICAL PROCESS UTILITIES
Generation systems, storage and distribution of purified and
injectable water and pure steam.
Sterile compressed air, vacuum, nitrogen, oxygen ...
Control and monitoring systems.
NON-CRITICAL UTILITIES
Electrical network (high and low voltage)
Industrial steam
Thermal fluids for HVAC and Processes
Fire Protection Systems
Control and Surveillance Systems
PROCESS EQUIPMENT
Manufacture in liquid forms: dispensing and formulation systems,
tanks, reactors, transfer lines including filtration and treatment
processes ...
Manufacture of solid forms, fractionation systems, transfer and
handling, vertical development plants, centralised dust collection …
Cleaning systems and/or sterilisation CIP/SIP.
Cold chain and thermal systems.
Decontamination systems, “in line” biowaste, Biological SAS ...
Automation systems, control and monitoring of production.
01 Process utilities
02 OIDE purified water generation system
We offer our customers a wide range of suppliers,
supplies and equipment.

8. ARGENTINA
Libertad 1133, Piso 3
Buenos Aires - C1012AAW
T +54 113 984 23 60
BRAZIL
Edificio Paulista Seguros
Rua Geraldo Flausino Gomes, 78 4º andar
04575-060 - Broklin
São Paulo (SP)
T +55 11 3336 4999
T +55 11 2594 7951
CHILE
Enrique Foster 20, of. 1102
Las Condes, Santiago de Chile
T +56 227 589 127
COLOMBIA
Carrera, 11A, núm. 93 A-62 Of. 304
Bogotá
T +57 1 2365 532
FRANCE
32, Boulevard Paul Vaillant-Couturier
93100 Montreuil
T +33 148 360 015
F +33 155 863 985
MOROCCO
Angel Pierre Parent et Mohamed
Smiha Espace. Paquet nº 305
Casablanca
T +212 522 311 413
F +212 522 311 413
MEXICO
Uxmal 380
Col. Narvarte
03020 México D.F.
T +52 55 3640 1400
PERU
C/ Tomas Ramsey Nº 930, Oficina 604
Magdalena del Mar, Lima
T +511 253 60 01
POLAND
Al. Jana Pawła II 80 lok. B22, klatka B
00-175 Warsaw
T +48 22 428 27 80
F +48 22 637 30 17
SPAIN
Avda. Roma, 25
08029 Barcelona
T +34 932 749 007
T +34 932 554 800
C/ Julián Camarillo 6A, 2ª planta
28037 Madrid
T +34 913 532 120
F +34 913 504 954
URUGUAY
Ruta 101 Km. 23.500
Parque de las Ciencias
Edificio Office 101 PB, Of. 007
14000 Canelones, Uruguay
T +598 2 682 97 25
cleanroom@comsa.com
www.comsa.com
A company of:
Committed to the future