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Our MISSIONS
Discover our trade
based in France, in the county of Rhône-Alpes.
Contracting owner
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Our assistance missions of contracting
Contracting owner
Our role is to assist the project owner, easing the decision-making, without replacing it.
That is why we work hand in glove with him to progressively precise the work object and the work environment that will be adapted to his needs.
Indeed, the content of the assistance missions and the related skills asked for is related directly to the nature of the decision maker's needs.
We can provide two types of assistance to the project owner :
Assistance in project management.
In this case, the skills to ensure this type of mission are cross-cutting because we rather meet a structuring need, an accompaniment need, a coordination need, and a project management need in the implementation of the decision maker's actions.
An engineering specialized assistance.
Therefore, we operate on a very peculiar domain to meet a need for advice or a one-time study need. The skills asked for mainly concern three domains :
> Process engineering,
> Design engineering,
> Equipment and utility engineering
Over the course of a project (feasibility phase, PO/FD phase, commissioning and qualification realization), these two types of assistance are alongside.
Engineering process
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MC SERV is an engineering expert firm for Super-clean industries and laboratories.
Engineering process
Our process and design engineering missions are closely connected.
Our process engineering missions :
Manufacturing process improvement (regulatory compliance, productivity, business strategy)
The drafting of the test protocol
Development of sampling plans
BPF course
Risk of contamination audit
Continuous improvement (5S, etc…)
Assistance in making files of the pharmaceutical business declaration with the ANSM.
Our design engineering missions :
Studies of various technical and economic scenarios in relation with customer sales forecasts.
To define the production capacities practicable depending on the selected scenarios.
To design processes in function of the possible work organization and of the capacity.
Analysis of existing production techniques : GMP flows modeling, process risks analysis, criticality analysis.
To analyze, to define then to dimension the needs in terms of :
- Staff (FTE)
- Surfaces necessary for activities
- Equipment (Washing machine, autoclaves, CIP/SIP, tanks)
- ergonomic Flows
Optimization of the equipment occupation rates.
Establish and dimension the premises according to the needs (production capacity, engaged teams, equipment size, ergonomic…).
Designs and establishments : position of the equipment dimensioned regarding a flows regulatory logic.
Rationalization of the stocks and storage areas.
Conveyors’ calculations : lengths and speeds to maximize the production lines efficiencies.
Equipment
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Here are the different types of equipment and uses we usually have the charge to set up at our customers’ places.
Equipment
Our mission is to find the best technical solution meeting your needs. To do so, we define the equipment to establish, or we develop prototypes.
We take charge of the sizing study and the specification draft of the equipment.
List of the equipment we currently are in charge of :
BULK
> Solute, storage preparation tanks
> Filter lines
> Centrifuge (refrigerated, with a continuous flow, ultracentrifuge...)
> Fermenters, Cytocultors and their regulatory consoles
> Pasteurizers
> Washing machines, washing cabins (in continuous flow or not)
> CIP/SIP
> Frontier autoclaves
> Drying furnace
MSFP filling and packaging
> Syringe washer
> Complete chain of aseptic syringe filling
> Aseptic filling chain of flasks
> Caps siliconizing and sterilization
> Freeze dryer
Standard laboratory equipment
> Laboratory refrigerators
> Laminar flow hoods, laminar safety cabinet
> pH-meters, Conductometers, Osmometers, Particule counters, etc...
Utilities process
> Water For Injection (WFI), Highly purified water production skid (HPW)
> Distribution loop of HPW
> Compressed air network, CO2, N2, O2...
> Steam generator
> A distribution network of steam process
> Computerized supervision of the production
> Environmental supervision system
Training
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We can build training modules adapted to all your needs and to the different levels of the representatives.
Training
MC SERV travels and provides initial training or updating the knowledge, thus organizes more practical workshops directly on your site.
At the end of the training, we evaluate our trainees to verify what they have learned. A training certificate is thus delivered to each of them.
Confined
laboratories
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MC SERV is a proactive partner of types Biosafety Level (BSL)1, BSLP2, BSL3.
Confined laboratories
The BSL1, BSL2, BSL3 types of laboratories are laboratories destined to the realization of manipulations on the natural or genetically modified pathogens in a confined environment.
*Bio Safety Level
BSL1, BSL2, BSL3 correspond to the risk level presented by the manipulated microorganism :
> Group 1 : zero or negligible risk microorganisms.
> Group 2 : low risk microorganisms.
> Group 3 : moderate risk microorganisms.
> Group 4: high risk microorganisms.
Thanks to our professional background in the industrial microbiology field, we are specialists in confined laboratories BSL1, BSL2, BSL3.
Indeed, we master the regulation and we are therefore able to assist you to the contracting owner for the realization of your project.
We set up :
> The engineering specifications of your project
> The follow-up of the fabrication
> The FAT & SAT commissioning tests of the facilities
> The QI, QO, and QP validation protocols
> Assistance for the SOPs
> The organization of the preventive maintenance.
Modular
laboratories
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MC SERV assists you in building modular laboratories.
Modular laboratories
The modular laboratories are laboratories "turnkey" delivered. They are composed of several modules, fully equipped in electricity, plumbing, heating, and interior finishes before leaving the fabrication plant. They can integrate the equipment of your choice. They are delivered by road transport onto your site then assembled. This method allows to obtain laboratories of any surface, on one or two levels.
One of the principal advantages of this technic is that a laboratory can, therefore, be entirely built in a very shorter time, at a very cheaper cost than a traditional laboratory.