Our Project Support capability is from URS to PQ and ongoing Requalification.
Our links with Mark Thompson Lifesciences mean that we can provide SME level support to the project definition, VMP, risk assessments, DQ and overall qualification approach based upon risk assessments. (Annex 15 compliance).
The MTL Projects engineers typically get involved at the equipment commissioning stage through to completion and have expertise in the following areas:-
- Qualification, requalification and maintenance of lab systems and the biotech industry
- Fridges, freezers, incubators, ovens (-196oC to +400oC)
- CO2 / humidity and speed controls for incubators, stability rooms, centrifuges.
- Porous load steam sterilisation cycle development to PQ / RQ
- Porous load air detector set up and full EN285 testing capabilities.
- Fluids loads and terminal sterilisation (steam, air / steam, superheated water)
- High security discard and make safe cat 3 and cat 4 machines
- Hydrogen peroxide sterilisation and decontamination
- Vacuum hydrogen peroxide sterilisation equipment
- Vaporised hydrogen peroxide units and Isolators
- Hydrogen peroxide and steam combined cycles
- Depyrogenation ovens and tunnels
- Freeze dryer qualification (shelf and product temperature mapping)
- Washing machines
- Parts washers
- SIP systems
- High purity water systems (raw water to point of use PW, WFI)
In these areas our scope of support is from commissioning to qualification / handover to production or process validation. We will develop the strategy for CQV, write the protocols and reports