Complete Vial Handling and Freeze Drying Solutions for Pharmaceutical Production

Accelerate Your Formulation Development Through to Final Product Tray Loading External Vial Washing Delivering Your Complete Aseptic Process Solution SP covers the complete range of aseptic processing tools and techniques, from cycle development, stability testing, pilot and clinical batch production through to full aseptic manufacturing and commercial production batches. Our expertize in processing and packaging is matched with in-depth software engineering capabilities and customer-orientated servicing and support. Responding to Industry Needs SP is committed to customer-driven innovation and...

SP – A Unique Blend of Expertise for Aseptic Processing, Lyophilization, Service and Support Modular Aseptic Processing Equipment Modular Aseptic Processing Overview Vial Washers Depyrogenation Tunnels Filling & Stoppering LyoConstellation™ Freeze Dryers Capping Machines External Vial Washers Row-By-Row & Semi-Automatic Loading Lyophilizers and Line of Sight™ The SP Line of Sight™ Approach Development & Scale Up Using Scalable Technologies & Process Analytical Technology (PAT) Tools LyoStar™ 3 Freeze Dryer ControLyo® Technology SMART™ Freeze Dryer Technology LyoFlux® TDLAS Sensor Tempris® Wireless...

Modular Aseptic Processing Giving You Ultimate Control for Small Batch Applications Injectable and Oral Products in Liquid and Powder Form Our modular “Versa-Line” fill-finish system and Line of Sight™ freeze dryer tools, technologies and equipment to provide a customizable solution using quick delivery standard modules for vial washing, depyrogenation tunnel, filling and stoppering, freeze dryer and freeze dryer loading systems, capping, external vial washers and trayloaders, to provide an integrated full line solution. • Smaller footprints: Each module is 6 feet long and standardizes isolator...

Modular Aseptic Processing Modular Aseptic Processing Equipment Vial Washers Range of low maintenance washers for low to high throughput manufacturing, guaranteed to reduce particulates by 1000 times Depyrogenation Tunnels Fully automatic depyrogenation tunnels for continuous aseptic processing of vials, syringes and ampules Filling and Stoppering Filling equipment capable of volumes ranging from 100 μL to 500 mL at up to 200 vials per minute Cappers For aseptic as well as oral applications, offering dependable vial protection at speeds of 200 caps per minute Lyophilizers Range of freeze dryers...

Modular Aseptic Processing Vial Washers Benefits • Dependably effective washing: Guaranteed reduction of particles by 1000 times and spray manifold eliminates the risk of chipping vials • Suitable for almost any manufacturing space: Small footprint and reduced water usage • Highly efficient and economical to run: Simple servodriven operation with fewer moving parts reduces maintenance and dedicated recipes, to ensure vastly reduced water usage • Extremely flexible: Easy and quick change between different sizes of glass or plastic vials low speed, semi-automatic vial washer with low output washing...

Modular Aseptic Processing Depyrogenation Tunnels Benefits • Highly effective sterilization: Guaranteed thermic cycle regardless of pressure fluctuations • Efficient automatic processing: Fully automatic, continuous aseptic processing offers increased efficiency for batch processing • All manufacturing requirements: Modules available for small and large batch sizes Fully Automatic Sterilization There are several different methods of inactivating pyrogens, including bacterial endotoxin’s, on vial surfaces. The most common and effective way is through dry heating to above 250°C, and both manually...

Modular Aseptic Processing Filling and Stoppering Benefits • Ideal for containment and sterility: Compatible with Restricted Access Barriers (RABs) or isolator enclosures • Exceptionally flexible: Available for manual or semi-automatic de-bagging and de-lidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers • Compliant with manufacturing regulations: 21 CFR Part 11 and audit trail capable Versatile and Complete Sterile Filling Solutions SP offers a choice of machines and dispensing methods for liquid filling of oral and ophthalmic bottles, vials, syringes...

Modular Aseptic Processing Filling and Stoppering Versatile and Complete Sterile Filling Solutions LI Linear Fillers LI Fillers enable linear filling, stoppering, tip placement, pump inserting and crimping or closing machines for bottles and vials up to 400 vials per minute. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic de-lidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. BI Rotary Fillers The BI Filler is a 1-up filling, stoppering and capping system for 2-100ml vials with output of up to 30 vials...

Modular Aseptic Processing LyoConstellation™ Freeze Dryer Benefits • Configured to order: Short lead-times to get you to market quickly and safely • Suitable for most throughput requirements: Range of freeze dryers with different shelf sizes from 1 m² to 13 m² and accommodates vials up to 100ml • Scalable and transferrable: SP Line of Sight technologies, PAT tools and software facilitate scale-up from development to clinical phases • Compact footprint: Ideal for most pilot scale areas; integrates with filling lines and semi-automatic systems Development, Pilot and Production Freeze Dryers LyoConstellation...

Modular Aseptic Processing Capping Machines Benefits • Compact design: Suitable for almost all manufacturing facilities • Dependable vial protection: Vertical force control during cap crimping and torque control/strain gauge feedback for screw capping applications • Ideal for containment and sterility: Compatible with Restricted Access Barriers (RABs) or isolator enclosures • Compliant with manufacturing regulations: 21 CFR Part 11 and audit trail capable Linear and Continuous Rotary Motion Capping The CRS, BI and LI models enable processing at 200 caps per minute for aseptic applications. Crimp...