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## Tour
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tour.name = Stelis Biopharma V2
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Our high-volume commercial use facilities were designed with FDA consultation, consisting of robust water system for WFI generation, storage and distribution, HVAC system, fire protect system and zero liquid discharge (ZLD) to support drug substance and drug product manufacturing.
Click here to visit entire PFS line.
Cartridge filling area
Glove integrity
Cartridge filling area
Unloading
Cartridge filling area
Infeed, stoppering, filling and sealing
PFS filling area
Delidding
PFS filling area
Loading and debagging
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PFS filling area
Filling and stoppering
Pen assembly area
Pen packaging
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Usefull Information
Navigating the Virtual Tour
The warehouse is well equipped for all types of material management, right from raw materials to finished goods, receipt and storage.
PFS line
Transfer to filling area
PFS for pharma and biopharma products using Bausch Strobel filling line integrated with Steriline isolator with an annual capacity of 28 million units.
Cartridge filling area
Cartridge washing machine
Vial line
Transfer to filling area
Cartridge line
Transfer to filling area
DS microbial line
Media room
Welcome to the world of Stelis!
This virtual tour of our North Bangalore facility will give you a 360 degree overview of:
Area Highlights:
1. Drug product area:
• Vials (liquid and lyophilized format)
• PFS
• Cartridges
• Devices
2. Packaging area
3. Drug substance area
• Microbial cell manufacturing
4. Utilities:
• Clean utility
• HVAC system
• Water system
5. Warehouse area:
• De-dusting booth
• Sampling and dispensing booth
• Walk-in incubator and cold storage
Process Overview:
1. Vial area
2. PFS area
3. Cartridge area
4. Microbial cell manufacturing area
Cartridge Filling with pen assembly for pharma and biopharma products using Bausch Strobel filling line integrated with Steriline isolator with an annual capacity of 40 Million units.
Liquid and lyophilised vials for pharma and biopharma products using Tofflon filling line integrated with isolator and Lyophilizer.
Annual Capacity: Liquid – 10 million, Lyophilized – 4 million
Mikron Ecoline System is a semi-automatic assembly line, validated for assembly of 3-part pen device with manual feeding. With change in the pallet design and IT programming the machine can accommodate multiple variants of pen devices and auto-Injectors.
Hybrid model with stainless steel fermenter (50, 300L and 1000L) for upstream and corresponding, single-use and conventional systems for downstream processing.
Our high-volume commercial use facilities were designed with FDA consultation, consisting of robust water system for WFI generation, storage and distribution, HVAC system, fire protect system and zero liquid discharge (ZLD) to support drug substance and drug product manufacturing.
The warehouse is well equipped for all types of material management, right from raw materials to finished goods, receipt and storage.
Secondary packaging comprising of labelling, syringe assembly, blister packing (PFS and cartridges) and auto-cartoning (Speed:100 cartons per min).
High-speed, High-volume aseptic filling capabilities.
Stelis’s state-of-the-art syringe filling facilities include high-speed filling lines that can provide billions of doses of biologics and sterile products by ensuring sterility and efficiency. Our capabilities include filling of single dose and multiple dose syringes ensuring compatibility with the delivery devices. With isolator-based technology, we offer the highest level of aseptic processing and with option to integrate safety device assembly lines and packaging infrastructure reliable supplies can be ensured for our customers.
PFS filling line
PFS filling area
Click here to visit entire Cartridge line.
Click here to visit entire Vial line.
Click here to visit entire DS Microbial line.
Mikron Ecoline System is a semi-automatic assembly line, validated for assembly of 3-part pen device with manual feeding. With change in the pallet design and IT programming the machine can accommodate multiple variants of pen devices and auto-Injectors.
Cartridge Line
Pen assembly area
Secondary packaging comprising of labelling, syringe assembly, blister packing (PFS and cartridges) and auto-cartoning (Speed:100 cartons per min).
DS microbial Line
Microbial cell culture platform
Efficient and streamlined manufacturing of clinical and commercial microbial biopharmaceuticals
Our state-of-art microbial manufacturing facility and highly talented scientific team experienced in developing, optimizing and scaling-up microbial fermentation and product isolation processes are committed towards developing high quality, commercially viable processes across pre-clinical development to commercial scale manufacturing. We use a hybrid model with stainless steel fermenter for upstream and single-use and conventional systems for downstream processing, designed for process scale-up studies at 50L to 300L to 1000L.
Save time, reduce risk, meet demand with automation.
Stelis offers comprehensive development and manufacturing services for products in vials, in both liquid and lyophilized drug product formats. Our automated vial filling capability with isolator technology ensures filling under aseptic conditions and prevents any risk of contamination.
Vial line
Vial filling area
Cartridge line
Cartridge filling area
Reliable CDMO partner for development and manufacturing of fill-finish cartridges.
The state-of-the-art cartridge filling facility is fitted with a high-speed machine from Bausch and Strobel. The highly automated facility ensures efficiency and speed at every stage of drug product manufacturing. We offer the highest level of CGMP aseptic processing with isolators and with integrated device assembly lines and packaging infrastructure, reliable supplies can be ensured to all our partners.