RSD Engineering Solutions sterilization department

1 RSD Engineering Solutions SL | www.rsd-engineering.com | info@rsd-engineering.com

About us

RSD Engineering Solutions is a young company with a huge and large experience in the sterilization field.

Its founder Romain Siegel, with its 10 years of experiences in Steam & Ethylene Oxide Sterilization, has developed great projects on the international level with customers as: Becton Dickinson, Merck Millipore, Synergy Health,…

Such a professional track has allowed him to set up the RSD Engineering Solutions SL company in 2014, dedicated to engineering of pharmaceutical, hospital, food and cosmetic sector.

We offer several services:

• Activities focused on Sterilization:

Sterilization consultancy

Design for equipment manufacturing (sterilizers, vacuum chambers,…)

Contract Ethylene Oxide sterilization services

• Engineering Activities:

Project design and analysis.

Control and quality engineering.

2

Main activities: • Pure steam, Superheated water and Ethylene oxide sterilization Consulting. • Pure steam, Superheated water and Ethylene oxide sterilization Design & manufacturing. • Contract Ethylene Oxide sterilization services.

The RSD Engineering Solutions objective is to develop customized solutions with high value products that suit to any customer profile. We advice our customers giving them technical answers to their design and manufacturing issues. We adapt our solutions and services to the customer requirements and we go with them since the initial phase of the project definition until its finalization.

What we engage in

3

Pure steam, Superheated water and Ethylene oxide sterilization consulting

RSD Engineering Solutions has a large experience and a deep know-how related to Steam sterilization, Superheated water and Ethylene Oxide Sterilization process (EO). That’s why we offer a wide range of services to meet all the needs in this area like:

4

•EO Cycle optimization; •Cycle validation for ethylene Oxide process (ETO); •EO, Superheated water and steam sterilization installation sizing, according customer requirements; •Utility calculations (N2, EO, chilled water, steam, etc…), needed for sterilization installation running; •Safety audit to fulfill the European directives 94/9/CE & 1999/92 CE (ATEX);

•Existing installation upgrade to be conformed to ATEX directive; •Parametrical release implantation on existing sterilizers; •Flammability calculations; •ROI calculations for a sterilization project investment; •Expertise and advices for technological, strategic and operative problems; •Protocol generations and executions;

•.

We have the Ism-ATEX certificate, level 2 for mechanical and electrical engineering. Certificate delivered by the French notified body INERIS. Many customers already rely on us like: Bbraun, Merck Millipore, Leventon, ….

If you are looking for counseling regarding pure steam, superheated water or EO sterilization processes, RSD Engineering Solutions will advise you efficiently in a total confidentiality. Our experience and know-how in sterilisation allow us to advise you in the correct way and give you efficient & adapted solutions.

5 More information about Pure steam, Superheated water and Ethylene oxide sterilization consulting

6

Equipment design & manufacturing (Sterilizers/Vacuum chambers/…)

RSD Engineering Solutions works in collaboration with the Inoxtorres SL based in Martorelles (Barcelona) for any equipment manufacturing. In that way, we cooperate with them for the design, qualification and programming for pharmaceutical, food and chemical equipment. We offer a complete range of pure steam sterilizers, superheated water sterilizers and ethylene oxide sterilizers (dedicated to a large variety of products like catheters, syringes, saline bag,…) that can be customizable. They are turnkey projects with high quality equipment, automatic control, well known brands, calibrated instruments, and a wide serie of safety devices. Any installations should fulfill standard guidelines cGMPs, based on FMEA and FDA, and ATEX normative should be applied for of ethylene oxide installations. We follow the most stringent normatives in Europe, United States, and others referring to pressure vessels.

We manage turnkey projects from the design phase (technical drawings, feasibility measures, manufacturing achievement, qualification with FDS, DQ, FAT) until M&E installation, commissioning and SAT, IQ & OQ execution in order to fulfil your requirements for the most adapted solutions. Also, we take care of the documentation aspect, delivering specific protocols, user manual, weld register, bill of material, etc.

7

Pure steam and Superheated water sterilizers The design of those equipment is totally flexible and customizable. They are turnkey projects with a GMP design, and they including (among other features):

•The sterilization chamber equipped with single or double door. •A technical area accessible from one side of the unit to facilitate maintenance operations. •All the instrumentation and components needed for proper and safe operations (visual alarm, sound alarm, hermetical seal - Bioseal)

Those sterilizers are designed to optimize the customer utilities (industrial steam, chilled water, electricity, etc.) and to control all the autoclaves. They are 100% automated, and the fulfill the pressure equipment regulation 2014/68/UE (97/23CE), and large steam sterilization EN-285, among others. Regarding the material in contact with either pure steam or superheated water, it is high quality AISI 304 stainless steel or AISI 316 as option.

We propose a serie of options (non-exhaustive list):

•Air detection system •PLC / SCADA •Software Validation •Additional panels •Pure Steam Generator •Trays, carts, transfer trolley •Spare parts

Pure Steam Sterilizer - PSS models

More information about Pure steam and Superheated water sterilizers/autoclaves

8

Installation configuration : •Gas dispensing room •EO vaporizer skid •Vacuum pump skid •Autoclave •Control room

Several options: •Vertical sliding doors •Parametrical release •Modulating pneumatic valves •Cooling system for jacket •Steam generator •Automated loading/unloading system •EO monitoring system •Preconditioning and degassing cells •Air purification system (Scrubber or Catalytic system) •Spare parts •Preventive maintenance

Ethylene oxide sterilizer In order to reduce the risks of those installations, INOXTORRES proposes a modular design that consists in dividing the zones under potential risks, according the probability to have an explosive atmosphere. They are projects totally customized with a very flexible design, where the customer can choose its own configuration with the chamber and its ancillary equipment. Our sterilizers are prepared to work with “All in one” cycles, but a wide range of options are available like preconditioning or degassing cells.

Ethylene Oxide Sterilizer - EOS models

More information about Ethylene oxide sterilizers/autoclaves

Contract Ethylene Oxide Sterilization service

RSD Engineering Solutions proposes an advanced treatment for Ethylene Oxide sterilization (EO) for your pharmaceutical or medical products. We fulfill the following regulations:

• ISO 13485:2003+ AC 2009 provision • ISO 11135:2014 • ISO 9001:2015 • 2014/34/UE (ATEX Directive)

The chambers are certified to work with a maximum temperature of 60ºC, with a pressure range from 50hPa to +0,5b.

9

We propose Contract sterilization solutions, flexible and adapted to the customer requirements, ensuring the process quality and safety, fulfilling the most stringent international normative and respecting the environment….

RSD Engineering Solutions develops customized solutions to their clients: •A cycle validation service adapted to the product technical requirements, •Preconditioning and degassing treatment in separate cells, •Ethylene Oxide sterilization routine cycles, with biological indicators (BI’s) internal or external, •A full report and very well detailed at the end of each sterilization cycle.

More information about Contract Ethylene Oxide Sterilization service

Contact us

RSD Engineering Solutions SL, Plaça del Mercat 10 08018 Barcelona Spain Phone:+34.608.796.692 Email: info@rsd-engineering.com Web: www.rsd-engineering.com

10