Engineering, manufacturing and validation of high-purity systems and process systems for the pharmaceutical and biotech industries
Masco Group s.r.l.
Settala (MI) · Ladenburg · Shanghai · Burlington (ON) · Hauppauge (NY) · Sannois · Stockholm · Malmö · Göteborg · Emtunga · Conshohocken (PA) · Charleville · Niel · Oss · BaselNew on Amplifa
About Masco Group
Masco Group is a group of specialized companies headquartered in Settala (Milan), Italy, that supports life-science companies across the complete manufacturing process chain. The group comprises the brands Stilmas (water treatment systems), Olsa (process systems including ThawMX® thawing systems for blood plasma fractionation), BCD (pharmaceutical plant engineering, including the HPAPI Superskid), KeyPlants (modular facility solutions), DOC (commissioning, qualification and validation), Masco Group Automation (PLC, SCADA and DCS automation), MascoLab (accredited testing laboratory), VILS and Techniserv (bioreactor and process systems, USA). Products include process vessels, reactors, high-purity systems in stainless steel and high-alloy materials, some glass-lined, as well as complete systems from individual components to turnkey projects. Customers come from pharma, biopharma, biotechnology, cosmetics, fine chemicals and food. Masco Group is privately owned by Ardian, the Borella family and management, and is active on five continents. In Germany, the group is represented by Stilmas Deutschland GmbH in Ladenburg.
- Site
- Settala (MI), Italy
- Processes
- Chemical and microbiological testing for process and product validation, Process and product validation for pharmaceutical and cosmetic manufacturing, Filter validation and ancillary tests, Primary packaging qualification, In-process material qualification (compatibility testing, extractables & leachables,, Analytical techniques GC/MS, Q-TOF, ICP/MS for extractables & leachables, Qualification and validation of pharmaceutical equipment and systems (critical utilities: water, Validation of computerised control systems (GAMP 5, 21 CFR Part 11)
- Materials
- High-alloy materials (process systems HPAPI Superskid), Glass-lined materials, PVC, Silicone, Viton, Stainless steel (test media for disinfectant efficacy), Stainless steel, High-alloy materials
- Certificates
- cGMP / FDA / EMA guidelines, GAMP 5 / 21 CFR Part 11, Annex 1 / PDA TR No. 26 / ASTM F838-15 / USP <1663>/<1665>
- Industries
- Pharma and biopharma, Biotechnology, Cosmetics, Fine chemicals, Food, Food (Techniserv)
- 01
Engineering and design
- 02
Manufacturing (stainless steel and high-alloy components)
- 03
Assembly and installation
- 04
Automation (PLC, SCADA, DCS)
- 05
CQV and validation
- 06
Laboratory analytics (MascoLab)
- 07
Commissioning and service
Materials & Processes
Stainless steel
Base material for pharmaceutical plants, process vessels and high-purity systems; testing of disinfectant efficacy on stainless steel surfaces.
High-alloy materials
Used in the HPAPI Superskid for reactors, transfer panels and isolators when handling aggressive chemicals.
Glass-lined materials
Alternative to high-alloy materials in the HPAPI Superskid for corrosion resistance and cleanability.
PVC
In-process material for compatibility, E&L and disinfectant efficacy testing.
Silicone
Elastomer material for in-process material qualification and biological testing.
Viton
Fluoroelastomer for seals in material qualification.
Systems & Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Chemical and microbiological testing for process and product validationTesting | – | – | – | – | – |
| Process and product validation for pharmaceutical and cosmetic manufacturingTesting | – | – | – | – | – |
| Filter validation and ancillary testsTesting | – | – | – | – | PVC, Silicone, Viton |
| Primary packaging qualificationTesting | – | – | – | – | – |
| In-process material qualification (compatibility testing, extractables & leachables,Testing | – | – | – | – | stainless steel, PVC, Silicone, Viton |
| Analytical techniques GC/MS, Q-TOF, ICP/MS for extractables & leachablesTesting | – | – | – | – | – |
| Qualification and validation of pharmaceutical equipment and systems (critical utilities: waterTesting | – | – | – | – | – |
| Validation of computerised control systems (GAMP 5, 21 CFR Part 11)Testing | – | – | – | – | – |
| Consulting: contamination control strategy, process validation, aseptic process simulation,Engineering | – | – | – | – | – |
| Engineering and design of facility modules, pods and high-purity process systemsEngineering | – | – | – | – | – |
| Industrial automation: PLC, DCS and SCADA/HMI systems for pharmaceutical manufacturingEngineering | – | – | – | – | – |
| Manufacturing of bioreactors and process systems (upstream and downstream bioprocessing)Engineering | – | – | – | – | – |
| HPAPI Superskid: high-containment processing system for highly potent APIs (reaction, filtration,Engineering | – | – | – | – | high-alloy, glass-lined materials |
| Blood plasma fractionation: thawing (ThawMX®), cold ethanol fractionation (Cohn),Engineering | – | – | – | – | – |
| Water treatment systems (Stilmas)Engineering | – | – | – | – | – |
| Electrically powered systems (E-Volution line)Engineering | – | – | – | – | – |
7 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Thawing tank (ThawMX®) | Olsa (Masco Group) ThawMX® | – | – | – | Settala, Italy |
| Temperature control units (TCU) | Olsa (Masco Group) | – | – | – | – |
| Transfer panels | Olsa (Masco Group) | – | – | – | – |
| Reactor vessels (HPAPI Superskid) | BCD (Masco Group) | 4 | – | – | Ireland |
| HPAPI containment isolators (fixed and mobile) | BCD (Masco Group) | – | – | – | Ireland |
| Distributed Control System (DCS) DeltaV | Emerson DeltaV | – | – | – | – |
| Laboratory instruments for chemical and microbiological analysis (GC/MS, Q-TOF, ICP/MS) | – | – | – | – | Settala (MI), Italy |
Additional services
Reference customers
Quality & Validation
MascoLab is an accredited laboratory with over 750 completed validation projects and more than 100 international customers. The laboratory equipment includes GC/MS, Q-TOF and ICP/MS; validations are performed in accordance with GAMP 5 and 21 CFR Part 11.
| Evidence | Settala (MI) |
|---|---|
| cGMP / FDA / EMA guidelines | |
| GAMP 5 / 21 CFR Part 11 | |
| Annex 1 / PDA TR No. 26 / ASTM F838-15 / USP <1663>/<1665> |
History
- 1982
Founding of Techniserv, Inc. in the USA as a provider of bioreactor and process systems
- 2024
BCD supplies key equipment for Eli Lilly's IE2B project in Kinsale, Ireland (ISPE Facility of the Year Award 2024, Innovation category)
- 2025
Acquisition of Techniserv, Inc. by Masco Group; majority stake by Ardian, the Borella family and management