Expanding our Capabilities
In 2021, BSM will be expanding its fill capacity and capabilities. This expansion will double our clean room and warehouse space, and bring a first-of-its-kind isolator-based robotic flexible filling line, complete with pulsed light capabilities to decontaminate RTU (ready to use) outer packaging. With this equipment, BSM will be able to fill larger lots of vials (RTU and bulk), cartridges, syringes and custom containers while advancing our quality and providing the ultimate in sterility assurance of your aseptically filled products.
Cleanroom Installation
- Cleanroom installation
- New Warehouse completed
- Laboratory Expansion
- WFI Sytem roughed in
Cleanroom Validation
- Validation Starts
(Cleanroom & WFI System) - Autoclave Arrives
- New Glove Integrity system installed and validated
New WFI System Validated
- New filler in Fedegari
(SAT, IQ/OQ - all completed in January) - Room 109 Modifications concurrent with filler install
- Autoclave validation
- WFI system validation completed
Depyro Tunnel Installed
- Washer/tunnel installed and validated
- Pulsed light system installed and validated
- Sterility isolator installed and validated
- New storage units installed and mapped
New Lyo Installed
- Lyo installed and validated
- WFI system cross over to existing system
- New Filler FAT
New Isolator Line Installed
- Isolator Arrives
- Isolator is Installed
- Validation Starts
Expansion Complete
- Validations for new isolator line are complete
- Production commences on new line
Cleanroom Installation
- Cleanroom installation
- New Warehouse completed
- Laboratory Expansion
- WFI Sytem roughed in
Cleanroom Validation
- Validation Starts
(Cleanroom & WFI System) - Autoclave Arrives
- New Glove Integrity system installed and validated
New WFI System Validated
- New filler in Fedegari
(SAT, IQ/OQ - all completed in January) - Room 109 Modifications concurrent with filler install
- Autoclave validation
- WFI system validation completed
Depyro Tunnel Installed
- Washer/tunnel installed and validated
- Pulsed light system installed and validated
- Sterility isolator installed and validated
- New storage units installed and mapped
New Lyo Installed
- Lyo installed and validated
- WFI system cross over to existing system
- New Filler FAT
New Isolator Line Installed
- Isolator Arrives
- Isolator is Installed
- Validation Starts
Expansion Complete
- Validations for new isolator line are complete
- Production commences on new line
Innovation to Come
isolator-based Flexible Filler
This line will include a double head flexible filler, capable of filling vials (RTU and bulk), cartridges, syringes, and custom containers all within an isolator.
DEPRYO Tunnel & RTU Tub Decon chamber
A depyrogenation oven with direct entry into the filling isolator will be included as well as a UV RTU Tub Decontamination Chamber.
High Capacity Lyophilizer & Capper
Direct entry to a lyophilizer from the filling isolator will be incorporated into the line, and the isolator will have an exit RABs with a capper.
Innovative Solutions
View a plungering demo of a double-head flexible filler. A similar filler will be incorporated into BSM’s isolator line in 2021.
Quality is never an accident.
It is always the result of intelligent effort.
That is why we cooperate with several leading suppliers to fabricate and integrate the most innovative technologies into our isolators.