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.
Q3 2020
- Cleanroom installation
- New Warehouse completed
- Laboratory Expansion
- WFI Sytem roughed in
Q4 2020
- New Glove Integrity system installed and validated
Q1 2021
- Analytical lab expansion complete
- New warehouse completed
Q2 2021
- Autoclave FAT started, completed, and arrives onsite
- WFI System validation started and completed
- Sterility Isolator FAT completed and arrives onsite
- Validation Starts
(Cleanroom & WFI System) - New filler in Fedegari
(SAT, IQ/OQ - all completed) - Room 109 Modifications concurrent with filler install
Q3 2021
- Autoclave validation completed
- Washer/tunnel installed
- Pulsed light system installed
- Sterility isolator installed and operational
- Lyo FAT completed and arrives onsite
Q4 2021
- Washer/tunnel validated
- Pulsed light system validated
- Lyo installed and validated
- Filler FAT arrives onsite, installed, and validated
- Positive diverting station arrives onsite, installed, and validated
- Lyo loading system arrives onsite, installed, and validated
Q1 2022 - Expansion Complete
- Combined automated filler line is assembled and validated
- Media fills on automated filler are completed
- Production commences on new line
Q3 2020
- Cleanroom installation
- New Warehouse completed
- Laboratory Expansion
- WFI Sytem roughed in
Q4 2020
- New Glove Integrity system installed and validated
Q1 2021
- Analytical lab expansion complete
- New warehouse completed
Q2 2021
- Autoclave FAT started, completed, and arrives onsite
- WFI System validation started and completed
- Sterility Isolator FAT completed and arrives onsite
- Validation Starts
(Cleanroom & WFI System) - New filler in Fedegari
(SAT, IQ/OQ - all completed) - Room 109 Modifications concurrent with filler install
Q3 2021
- Autoclave validation completed
- Washer/tunnel installed
- Pulsed light system installed
- Sterility isolator installed and operational
- Lyo FAT completed and arrives onsite
Q4 2021
- Washer/tunnel validated
- Pulsed light system validated
- Lyo installed and validated
- Filler FAT arrives onsite, installed, and validated
- Positive diverting station arrives onsite, installed, and validated
- Lyo loading system arrives onsite, installed, and validated
Q1 2022 - Expansion Completed
- Combined automated filler line is assembled and validated
- Media fills on automated filler are completed
- 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.