Lyophilization Product Line Overview

Transcription

1 Lyophilization Product Line Overview

2 Introduction Contents SP Scientific offers the broadest lyophilization range available, and is the only United States based manufacturer of complete aseptic vial fill-finish lines. The SP Scientific family includes FTS, Hull, PennTech and VirTis. To provide the most suitable solutions within today s competitive research, development and production environments, SP offers a wide selection of options including: refrigeration packages, condenser capacity, shelf configuration, control software, endpoint detection, cleanroom configurations and many others. Our technical sales team is always ready to help you configure a system that will best meet your technical and budgetary needs. Our client relationship starts before the sale and lasts a lifetime. LyoLearn hands-on training, webinars and technical briefs are designed to provide continuing education on topics of interest to the lyophilization scientist, engineer and operator. When you choose a SP Scientific freeze dryer, you are choosing a technical support team invested in your success. We are here to answer your equipment and application questions, as well as provide troubleshooting support. For further information, please visit or contact us at or Lyo123@SPScientific.com. BenchTop Manifold Lyophilizers 3 Freezemobile Manifold Lyophilizers 4 AdVantage Tray Lyophilizers 5 Genesis Pilot Lyophilizers 6 Ultra and VirTual Small Production Capacity Lyophilizers 7 LyoStar3 Cycle Development and Optimization Lyophilizers 8 ControLyo Nucleation Technology 9 SMART Freeze-Dryer Technology 10 LyoFlux : Tunable Diode Laser Absorption Spectroscopy (TDLAS) 11 Benchmark Pilot to Production Lyophilizer 12 Hull Clinical to Production Lyophilizers 13 PennTech Auto Loading and Unloading Systems 14 Control Systems At-a-Glance 15 Services & Support 16 LyoTech Center 18 2

3 BenchTop Pro Manifold Lyophilizers Performance and Versatility in a Compact Unit Easily configured for your application Condenser capacity Capacity 3, 8 and 9 liters Temperature -55 C, -75 C, -85 C -105 C option for superior trapping of organic solvents Hot gas defrost for quick turn around Drum, tree or vertical manifolds available Optional heated shelves for rapid tray drying Touch Screen controller Easy to review display for continuous monitoring User selectable pressure control Vacuum display selectable in mtorr, ub or Pa Power saving features Optional stand-alone shell bath decreases freeze drying time Control: Omnitronics (See controllers on page 15) Manifold options: MANIFOLD ACCESSORIES SOLD SEPARATELY W 15 1 /2 ( 39.4 cm) D 28 1 /2 ( 72.4 cm) H 23 (58.42 cm) H 17 ( 43.2 cm) WITHOUT MANIFOLD and more... 3 TYPICAL APPLICATIONS Laboratory research Protein purification Products for analysis plant material, tissue and cells, waste products, bacteria Aqueous or organic samples This product has a CO 2 e range between 0.01 and 6.77 tonnes, dependent upon the options selected. BENCHTOP PRO bit.ly/2ggctt7

4 Freezemobile Large Capacity Manifold Lyophilizers Have a Critical Freeze Drying Need? The Answer Just Rolled Up! Condenser configuration can be matched to solvent types and loads Floor standing and fully mobile Condenser options 25 liter or 35 liter capacity Temperatures to -85 C Hot gas defrost and smooth wall for quick turn around Drum, tree, or vertical manifolds available Material options of acrylic or rugged stainless steel Full range of glassware and other accessories Touchpad control panel Easy to review display for continuous monitoring User selectable pressure control Vacuum display selectable in mtorr, ub or Pa Power saving features Integrated vacuum pump with easy maintenance access to oil drain/fill Optional stand alone or built-in shell freezing bath Control: Sentry (See controllers on page 15) H 37 (94.0 cm) W 35 ( 89.0 cm) BASED ON FM25 D 29 ( 74.0 cm) MANIFOLD ACCESSORIES SOLD SEPARATELY The Freezemobile shell bath increases ice surface area which helps to decrease drying time TYPICAL APPLICATIONS Central facility or machine room ideal for multiple users Laboratory research Protein purification Products for analysis plant material, tissue and cells, waste products This product has a CO 2 e range between 0.47 and 9.02 tonnes, dependent upon the options selected. 4

5 AdVantage Pro and AdVantage 2.0 Bench Top Tray Lyophilizers AdVantage Pro Features AdVantage 2.0 Features Space Saving Efficient Development Freeze Dryer Compact bench top system with the capabilities of a larger pilot R&D freeze dryer Condenser capacity of 6 liters with temperature options to -85 C Flexible on-board control package Up to 12 programmable segments in the freezing stage Annealing/thermal treatment step to enhance product freezing for better drying Up to 16 programmable freeze drying segments On-board storage of up to 16 cycles, with easy access Adjustable pressure control throughout cycle, user selectable in mtorr, ub and Pa Four product thermocouples may be used for effective monitoring Systems configured with one, two or three stainless steel shelves, plus one radiant Uniform shelf temperature control by recirculating fluid Temperature control from -55 C to +60 C, ±1 C Optional stoppering Shelf Capacity Quick Comparison: Up to ml vials (14.75mm OD x 40 mm high with partially inserted stopper) using all three shelves Control: Intellitronics (See controllers on page 15) Condenser capacity of 3.5 liters with minimum temperature of -85 C Single shelf system cooled by direct gas expansion Aluminium alloy casting with corrosion-resistant surface Temperature as low as -70 C with control from -55 C to +60 C Includes two product thermocouple probes Shelf Capacity Quick Comparison: Up to 399 2ml vials (14.75mm OD x 40 mm high with partially inserted stopper) Control: Wizard (See controllers on page 15) 5 H 29.7 (754 cm) D 25.7 ( 653 mm) W 22.2 ( 565 mm) MANIFOLD ACCESSORIES SOLD SEPARATELY TYPICAL APPLICATIONS Laboratory research and development freeze drying 96-well plates Serum bottles or vials Small batch R&D freeze drying AdVantage 2.0 Bulk products for analysis plant material, tissue and cells, waste products This product has a CO 2 e range between 0.26 and 6.77 tonnes, dependent upon the options selected. INTELLITRONICS SIMULATOR bit.ly/adv-controller

6 Genesis Pilot Lyophilizers for Product Development and Small Batch Production The Most Versatile Pilot Lyophilizer Available Highly configurable system with many options, able to be tailored to your application Condenser options 25 liter or 35 liter capacity Choice of condenser temperatures to -85 C Hot gas defrost and smooth wall for quick turn around Range of configurable control systems providing best fit of control to your application Optional Pirani capacitance manometer and/or barometric end point determination Systems configured with between three and six stainless steel shelves, plus one radiant Capacity offering 1.5 ft 2 /0.14 m 2 to 9.18 ft 2 /0.85m 2 Uniform shelf temperature control by recirculating fluid Temperatures from -55 C to +65 C, ±1 C Optional stoppering (up to five shelves only) Shelf Capacity Quick Comparison: Up to ml vials (14.75mm OD x 40 mm high with partially inserted stopper) using a 5 shelf stoppering unit Control: Wizard, Encore, or LyoS (LyoS may be 21 CFR Part 11 Compliant) (See controllers on page 15) H 73 1 /2 ( 187 cm) TYPICAL APPLICATIONS Laboratory research and development Small production freeze drying Diagnostic kits 96-well plates Serum bottles and vials Bulk products for analysis plant material, tissue, collagen, bone, waste products GENESIS bit.ly/2gkckhq W 40 ( 102 cm) STANDARD CONFIGURATION D 30 ( 76 cm) This product has a CO 2 e range between 0.47 and 9.02 tonnes, dependent upon the options selected. Available in Cleanroom Configuration 6

7 Ultra & VirTual Small Production Capacity Lyophilizers Ultra Ideal for Applications Requiring a High Shelf Surface Area Highly configurable versatile system add options to build to your needs Range of configurable control systems providing best fit to your application Choice of condenser temperatures to -85 C Uniform shelf temperature control by recirculating fluid Temperatures from -55 C to +65 C, ±1 C Optional stoppering H 75 3 /4 ( cm) VirTual Ultra Ultra for Smaller Solvent Loads Eight to fifteen shelf capacity (plus one radiant) 6.12 ft 2 /.57m 2 to ft 2 /2.13m 2 External condenser of 35 liter or 50 liter capacity VirTual for Higher Solvent Loads Four to ten shelf capacity (plus one radiant) 6.12 ft 2 /.57m 2 to ft 2 /1.42m 2 Internal coil condenser Shelf Capacity Quick Comparison: Using 2ml vials (14.75mm OD x 40mm high) with a partially inserted stopper Ultra: up to ml vials in a 15 shelf system VirTual: up to ml vials in a 10 shelf system Control: Wizard, Encore, or LyoS (LyoS may be 21 CFR Part 11 Compliant) (See controllers on page 15) H 75 3 /4 ( cm) VirTual W 25 ( 64 cm) Available in Cleanroom Configuration D 78 ( cm) TYPICAL APPLICATIONS Tissue banking Small production freeze drying Diagnostic kits Serum bottles and vials VIRTUAL bit.ly/2h0nydk D 38 3 /4 ( 98.0 cm) This product has a CO 2 e range between 0.47 and tonnes, dependent upon the options selected. 7 W 50 ( cm)

8 LyoStar3 Cycle Development and Optimization Lyophilizers The Ultimate Cycle Development Tool for R&D Professionals Configured with the latest process instrumentation for in-depth cycle information SMART (page 10) cycle optimization technology ControLyo (page 9) controlled ice nucleation technology Tunable Diode Laser Absorption Spectroscopy (page 11) process monitoring Turnkey, fully configured freeze dryer Designed and built like a production dryer to facilitate scale-up External 30 liter condenser with minimum temperature -85 C Optional configuration for working with organic solvents System configured with between one and four stainless steel shelves, plus one radiant Capacity offering 1.5 ft 2 /0.14 m 2 to 7.6 ft2/0.71m 2 Uniform shelf temperature control by recirculating fluid Temperature from -70 C to +60 C, ±1 C Optional stoppering Shelf Capacity Quick Comparison: Up to ml vials (14.75mm OD x 40 mm high with partially inserted stopper) using a 4 shelf stoppering unit Control: LyoS (See controllers on page 15) Available in Cleanroom or Isolator Compatible Configurations LYOSTAR 3 H 96 ( cm) W 33 ( 84.0 cm) D 43 ( cm) TYPICAL APPLICATIONS Specifically designed for formulation development Ideal for high value pharmaceutical and biological products in vials Cycle optimization and scale-up Lyophilization of products with organic solvents in addition to water bit.ly/lyostar This product has a CO 2 e range between 5.34 and tonnes, dependent upon the options selected. 8

9 ControLyo Nucleation Technology Freeze Drying Cycle without Nucleation Control Freeze All Vials Uniformly and Consistently Every Time ControLyo Technology pressurizes the freeze dryer product chamber with filtered inert gas and then quickly depressurizes the chamber. The depressurization causes instantaneous ice nucleation in all vials in the product chamber. ControLyo can be used to freeze at the warmest possible temperature and minimizes degree of supercooling. In addition, ControLyo yields large ice crystals resulting in the shortest possible drying time and providing increased product homogeneity because all vials freeze at the same time. ControLyo does not require significant addition of utilities or introduce foreign matter or crystals into the vials. ControLyo Technology is an option on SP Scientific pilot, clinical and production freeze dryers and may be retrofitted onto qualified existing units regardless of manufacturer. Benefits: Shorter primary drying times and an optimized cycle Less aggregation and better stability of protein formulations Technology conforms to the Quality by Design framework Reduces waste by eliminating almost all vial breakage Improved cake appearance, cake morphology and product homogeneity Shortened product reconstitution time Utilizing ControLyo Nucleation Technology Super-Cooling and Nucleation High degree of Super-Cooling Smaller ice crystals Smaller pores in dried matrix Increase in product resistance Rp Decrease in rate of sublimation Longer freeze drying cycle times CONTROLYO DEMO Low degree of Super-Cooling Large ice crystals Larger pores in dried matrix Decrease in product resistance Rp Increase in rate of sublimation Shorter freeze drying cycle times 9

10 SMART Freeze Dryer Technology This patented technology has resulted from extensive partnering with freeze drying experts. Developed exclusively with leading academics at The University of Connecticut and Purdue University, it has been recognized as one of the most important breakthroughs in freeze drying control in recent years. Benefits: Provides instant feedback on product resistance, heat flow, and product temperature at the sublimation interface Determines and verifies your optimized primary drying cycle in three runs or less Allows researchers to spend more time on value added activities such as cycle optimization with Quality by Design (QbD) approach Case Study #1 #1 Detail Number of Experimental Runs Performed Estimated Development Time (Days) Analytical (DSC) Costs Labor Costs Material Costs Total Costs per Development Program Development Programs per Year Total Annual Cycle Development Costs Traditional Approach $1,000 $36,060 $93,750 $130,810 8 $1,046,480 SMART Approach 2 9 $1,000 $2,412 $75,000 $78,412 8 $627,296 Savings 8 76 $0 $33,648 $18,750 $52, $419,184 SMART is available on the LyoStar3 freeze-dryer, including an upgrade option for existing LyoStar3 systems. Case Study #2 #2 Detail Detail Traditional Approach SMART Approach Savings Number of Experimental Runs Performed Estimated Development Time (Days) Analytical (DSC) Costs Labor Costs Material Costs Total Costs per Development Program Development Programs per Year Total Annual Cycle Development Costs 8 63 $1,000 $30,480 $25,000 $56,480 8 $451, $1,000 $2,820 $25,000 $28,820 8 $230, $0 $27,660 $0 $27, $221,280 10

11 LyoFlux : Tunable Diode Laser Absorption Spectroscopy (TDLAS) Monitor Pharmaceutical Freeze Drying Water Vapor Mass Flow Rate Sensor TDLAS based sensor measures water vapor concentration and gas flow velocity during the freeze drying process. These measurements can be combined to calculate the instantaneous water vapor mass flow rate and the ice sublimation rate. The sublimation rate determination can be combined with a heat and mass transfer model used in freeze drying to determine a Key Process Parameter (KPP) during freeze drying, the product temperature, which is closely linked to product quality. The LyoFlux sensor provides real-time measurements that will enable process control during the freeze drying process and the use of this technology enhances the understanding of product qualities. Benefits: PAT tool for process scale-up and process control Assess freeze dryer equipment capability limits Monitor process and product parameters Develop freeze drying cycles based on Quality by Design (QbD) procedures Applicable to laboratory, pilot and production scale freeze dryers Continuous, non-intrusive monitoring of lyophilization processes Water vapor, concentration, flow velocity, (V) & water mass flow (dm/dt) measurements Continuous mass balance determination Determination of Primary and secondary drying endpoints Average product temperature Average product resistance Vial heat transfer coefficients Freeze dryer performance qualification 11 LYOFLUX (TDLAS) bit.ly/lyoflux

12 Benchmark Lyophilizers for Pilot-to-Production Freeze Drying Custom Built for Today with an Eye to the Future Configured to meet your facility/project specifications Shelf area up to 30m 2 stoppering or 39m 2 (bulk) Uniform shelf temperature +/-1 C Internal or external condenser choices with plate or coil technology; flexible orientation to chamber Bio-seal flange for clean room installation; True Bioseal; or welded isolator interface options Critical systems redundancy Control systems with superior historical trend functionality Control: Encore or LyoS (See controllers on page 15) TYPICAL APPLICATIONS Pharmaceuticals/Biological clinical batch production Diagnostic kits Tissues Nutraceuticals Medical devices BENCHMARK bit.ly/spbenchmark Vial Capacity Chart by Model Vial Capacity, (approx.) Virtis BM1000 Virtis BM2000 Virtis BM3000/3500 Virtis BM4000/4500 Virtis BM5000/5500 Virtis BM mm diameter (3ml vial) 25mm diameter (10ml vial) 52mm diameter (100ml vial) , ,800 11, ,000 20, ,600 32, This product has a CO 2 e range between 0.01 and 100+ tonnes, dependent upon the options selected. 12

13 Hull Clinical-to-Production Lyophilizers Reliability and Longevity to Maximize Product Yield Year After Year Shelf areas from 24 ft 2 (2m 2 ) to 450 ft 2 (42m 2 ) A variety of layouts available including multiple floor, mechanical mezzanine and pass through options Vessel ratings of 30 psig of maximum allowable working pressure Suitable for SIP and/or ControLyo Powerful condensers with Efficient vapor trapping and easy CIP coverage verification for validation purposes Smart Cool - Highly efficient PLC refrigeration control allows the use of variable frequency drives to save energy in the parts of the cycle that require less cooling Preventative refrigeration diagnostics and monitoring of the refrigeration system Optional LN 2 refrigeration system Built to National Electric Code, CE, or UL 508 electrical specifications as required TDLAS non-intrusive/invasive PAT tool for water vapor measurement Full validation documentation and 21 CFR Part 11 compliant controls Control: LyoLink or LyoS (See controllers on page 15) Available with ControLyo Technology HULL Vial Capacity Chart by Model Vial Capacity, (approx.) Hull 120 Class Hull 240 Class Hull 300 Class Hull 450 Class 18mm diameter (3ml vial) 25mm diameter (10ml vial) 52mm diameter (100ml vial) 27,360 16, ,720 33, ,400 41, ,600 64,350 14,850 bit.ly/sphull TYPICAL APPLICATIONS Pharmaceutical and biotechnology production This product has a CO 2 e range between 0.01 and 100+ tonnes, dependent upon the options selected. 13

14 PennTech Automatic Loading and Unloading Systems Complete Vial Handling Solutions SP PennTech brand offers an array of freeze dryer loading options, from fully automatic row by row systems to AGV (Automated Guided Vehicle) based systems to semi-automatic systems including single and dual trayloaders. Systems can be installed as part of a new freeze dryer installation or as a retrofit with existing freeze dryers. Features: Single or Dual loading stations Can handle vials from 1cc - 500cc, glass or plastic Designed to handle trays up to 610 mm (24 in) wide (open end) and up to 610 mm (24 in) deep Tray materials can be metal, cardboard, corrugated plastic, or rigid plastic Tool free changeover No format/change parts required Menu-driven, PLC-assisted changeover Automatic nesting Optional automatic containment ring lowering system for freeze drying applications Optional vision system available for vial counting, product consistency and configuration Consistency in trayloading, always the same number of vials per tray Non-stop loading, even when replacing a full tray Aseptic Vial Washing, Sterilization, Filling, Stoppering, and Capping Also Available Each system can be equipped with: Laminar Air Flow units (LAF) Open Restricted Access Barrier System (o-rabs) Closed Restricted Access Barrier System (c-rabs) Isolator PENNTECH bit.ly/penntech 14

15 Control Systems At-A-Glance Capabilities: Wizard 2.0 Omnitronics Intellitronics Encore LyoS LyoLink Up to 12 Thermal Treatment Steps and up to 17 Drying Steps 12 Thermal Treatment Steps and 20 Drying Steps with 3 Selectable Operation Modes 4-8 Product Probes 9-16 Product Probes 17+ Product Probes 15 Integrated Performance and Vacuum Integrity Testing Historical Data Trending Batch Reporting Manual Pressure Rise (Barometric Endpoint) Testing (not available on AdVantage 2.0) Automatic Pressure Rise (Barometric Endpoint) Testing Automated Pirani/CM Differential Feedback Clean-in-Place (CIP) Cycle and/or CIP Skid Integration Steam-in-Place (SIP) Sterilization Cycle Multi-Level Security Capability 12 Security Groups with Multi-Level Capability Security Integration with Microsoft Windows. 21 CFR Part 11 Compliance Capability with SQL Database RS-232 Communications Ethernet Communications Cycle Customization Multiple Architectures Including Virtual Machine, Server/Thin-Client PM Features such as Device Runtime and Refrigeration Trends with Alarm Capability Sub-door Shelf Position Indexing to within +/-1mm

16 Service & Support Our customer service begins when we review your process requirements, discuss your needs and answer all your questions. It continues throughout the entire design, manufacturing and testing process. Additional Value-Add Services from SP Scientific The following products and services are available for SP Scientific equipment. Installation Services Set-up and configuration Rigging, air caster moving, precision laser leveling, floor protection, safety monitoring Utility verification Start-up Validation Support Services Factory Acceptance Testing (Includes document and testing) Control System Testing System Integration Testing Freeze Dryer Validation Guide and Workbook (IQ/OQ) Site Acceptance Testing Equipment Qualification (IQ/OQ) Control System Software Qualification (IQ/OQ) 16

17 bit.ly/serviceandsupport Service, Equipment Management, Maintenance and Repair Whether performing routine and preventative maintenance or assisting with crisis management, SP s global direct service team and factory trained distributor personnel are regularly hailed for their responsive and experienced support. On-site & Return-to-Service-Center capabilities Local service relationships with global presence Preventative Maintenance Packages Service programs to fit your facility/production Use of parts sourced from your preferred suppliers Training for operators, technicians and maintenance personnel Service all manufacturer s systems Lyo Renewal freeze dryer rebuilding services What our customers are saying... Maintenance is well done: the company has great technical service by phone call. SP technicians were called to service a unit in an area under less than optimum conditions. Unit was on a double door with one door in a warm and extremely dry condition, and the other door located in a cold and dry room - all while garbed head-to-toe in disposable Tyvek garments and nitrile gloves. They completed the work promptly, and with no disturbance to the ongoing work in the area. I commend them for their excellent service. SERVICE & SUPPORT...arrived on time in the morning, diagnosed the problem quickly, made the necessary repairs, and had the system running correctly by mid-morning. Also performed preventative maintenance that day. Both services were provided in a timely manner which allowed us nearly seamless operation with minimal down time - thanks! 17

18 LyoTech Center SPScientific.com/LearningCenter SP Scientific Offers In-Depth Resources for Lyophilization Scientists We are committed to helping our customers achieve the best possible results from their investment and so we offer the following resources online. LyoLearn Webinars*: This free online monthly seminar series has topics of interest to lyophilization scientists and is presented by industry experts. Each online LyoLearn Webinar is archived for future reference and includes the PowerPoint presentation. LyoLearn Tech-Brief*: LyoLearn Tech Briefs are articles, case studies and technical notes provided by our associates or consultants to present fundamental freeze drying information. LyoModelling Calculator: Developed by the University of Connecticut s Dr. Michael Pikal, Dr. Robin Bogner, and Royce Labriola in collaboration with SP Scientific, the New LyoTool helps users model a freeze drying cycle and print reports. Hands-On Training: multi-day training sessions held in an SP Scientific laboratory that offers participants a chance to use freeze drying equipment as they learn techniques from industry experts. LYOTECH CENTER *Available in multiple languages. bit.ly/2gg1dgn 18

19 ...and more! Educational Seminars: these one-day lyophilization seminars are led by industry leaders and held in locations around the world. LyoTools: LyoTools contains a variety of tools and programs that may be helpful in either day-to-day lyophilization research, or in helping customers to decide their lyophilization requirements. Lyo Consultants: a listing of consultants not commercially affiliated with SP Scientific. Allied Technology: includes links to companies that offer products commonly utilized in freeze drying, but not offered by SP Scientific. Courses and meetings: a listing of educational opportunities for lyophilization scientists offered by organizations other than our own. Publications: links to publications and journals of interest to lyophilization scientists and users of lyophilization equipment. Organizations: details of organizations and groups of interest to the lyophilization community. Educational facilities: a listing of universities and colleges that provide educational opportunities in freeze drying. Shows and conferences: a directory of trade shows and venues of relevance to lyophilization scientists. 19

20 SP Scientific Facilities Corporate HQ: 935 Mearns Road, Warminster, PA USA Additional Facilities: Stone Ridge, NY USA Gardiner, NY USA Ipswich, Suffolk UK Toll Free: (800) Local: (845) Fax: (845)