Advanced Freeze Drying System

Advanced Freeze Drying System

reeze Dryers and Lyophilization Support Services Hull, an SP Scientific brand, designs, fabricates and assembles sophisticated pilot and production freeze dryers, lyophilizers, and associated lyophilization process sub-components under an ISO 9001:2008 registered quality management system. Hull supplies freeze drying equipment to the pharmaceutical, biotechnology, diagnostic and veterinary markets. A particular product strength is supplying large custom cGMPlyophilization systems for the production of parenteral and veterinary pharmaceuticals.

Hull provides complete project support from design specifications through engineering, fabrication, GAMP 5 documentation packages, installation, service, and parts. Hull’s line of lyophilization process equipment includes a broad range of standard and custom freeze dryers, autoloading systems, and process skids. Full System Integration and Factory Acceptance testing, IQ, OQ and SIT documentation packages are offered by Hull in compliance with all applicable regulations.

  • 25 PSIG ASME Code Pressure Vessel Rating
  • Automatic Perimeter Locking Door
  • Heavy-Duty Shelf Construction (Maintains flatness for the life of the system)
  • Double Latching
  • Stainless Steel Stoppering Ram Bellows
  • Smart Cool 4.0 Electronic Refrigeration Control
  • Lyo-Link is 21 CFR 11 Configurable PC/PLC based Control System

Standard Freeze Dryer Options

Refrigeration with Smart Cool®

  • Reciprocating Compressors
  • Screw Compressors
  • LN2 Refrigeration
  • Cascade Refrigeration

Heat Transfer

  • Direct Expansion Condensing
  • Flooded Loop Condensing
  • Internal Condensing
  • External and Hypro® Condensing

Vacuum

  • Rotary Vane Vacuum Pumps
  • Rotary Piston Vacuum Pumps
  • Mechanical Booster Vacuum Pumps
  • Liquid Ring Vacuum Pumps
  • Dry Screw Pumps

Sterilization

  • Clean-in-Place
  • Steam-in-Place
  • Vaporous Hydrogen Peroxide

Loading

  • Auto-locking doors
  • Sub-doors
  • Pass-through
  • Semi-Manual Loaders & Unloaders
  • Automatic Loading & Unloading

Compliance

  • GAMP 4
  • 21 CFR 210
  • 21 CFR 211
  • ASME Sect. VIII Div. 1 Pressure Vessels
  • Seismic Certification

Documentation

  • Borescope Maps
  • Materials Certifications
  • System Integration Testing
  • Factory Acceptance Testing
  • Installation Qualification
  • Operational Qualification

Retrofit Options

  • Controls Upgrades
  • Refrigeration Upgrades
  • Product Shelves
  • Process Vessels
  • Vacuum Upgrades
  • Clean-In-Place Retrofits
  • ControLyo™ Nucleation On Demand Technology

Service Options

  • Installation
  • Startup
  • Training
  • Validation Assistance
  • Preventative Maintenance

SP Hull Production Freeze Dryer / Lyophilizer

 

Hull designs, manufactures, installs, and services cGMP vacuum freeze drying equipment for the reliable lyophilization of a wide range of pharmaceutical and biotech products. We have a broad line of standard freeze dryer models and ancilliary equipment such as Clean-In-Place skids and autoloading and unloading systems. We also provide highly customized equipment upon request, utilizing fifty-plus years of industry experience and our in-house engineering and fabrication resources.

Hull offers full System Integration and Factory Acceptance testing, and IQ, OQ, and SIT documentation packages using the GAMP 5 model. Installation services and after-sale technical service and replacement parts are also available

SP Hull Lyostar 4

SP Hull Lyostar4 is an advanced development freeze dryer ideal for rapid lyophilization cycle development, optimization and scale-up. It incorporates the very latest innovations in freeze-drying technology. Ensure precise process control and reliability and protect the valuable product. Fully PAT enabled Lyophilizer that enables get the product to the market faster.

 

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SP Hull Production Freeze Dryer / Lyophilizer

Lyophilizer Selection Guide

These freeze dryers are only our starting points – we will be glad to use our 50-plus years of experience to custom engineer a freeze dryer to your exact requirements.

Model Shelf Size W x D inch (mm) Product Area sq.ft (sq.m) Ice Capacity Kgs
24FS40 24 x 36 (610 x 914) 24 (2.23) 40 – internal
24FXS50 24 x 36 (610 x 914) 24 (2.23) 50 – external
48FS75 24 x 36 (610 x 914) 48 (4.46) 75 – internal
48FXS75 24 x 36 (610 x 914) 48 (4.46) 75 – external
72FS100 36 x 48 (914 x 1219) 72 (6.69) 100 – internal
72FXS100 36 x 48 (914 x 1219) 72 (6.69) 100 – external
120FS175 36 x 48 (914 x 1219) 120 (11.15) 175 – internal
120FXS200 36 x 48 (914 x 1219) 120 (11.15) 200 – external
220FXS450 48 x 60 (1219 x 1524) 220 (20.44) 450 – external
450FXS800 60 x 72 (1524 x 1829) 450 (41.81) 800 – external

How to read a Hull Freeze Dryer Model Number

Example: 650 F X S 1100 – SS 25C

The 650 indicates the usable shelf product area in square feet. We have made freeze dryers from 2 ft22 (.19 m22) to 1080 ft22 (100 m22). So far.

The F refers to a freeze dryer as opposed to a shelf dryer. We also make shelf dryers.

The X indicates a freeze dryer with an external ice condenser. We make both internal and external ice condensing systems.

The S refers to a freeze dryer with shelf stoppering capability. We also make freeze dryers with fixed shelves. Our standard stoppering pressure is adjustable to 10 lbf/in22 (7031 kg/m22); our highest has been 40 lbf/in22 (28123 kg/m22). So far.

The 1100 indicates the lyophilizer’s ice condensing capacity as liters of water. We have made condensing systems with capacities from 5 liters to 1200 liters. So far.

The SS indicates stainless steel construction of all product contact and cleanroom surfaces.

The 25C indicates an ASME Code Certified pressure rating of 25 lbf/in2 gauge. Hull designs and fabricates its vessels in-house and is certified to the American Society of Mechanical Engineers Section VIII Division 1 requirements for Unfired Pressure Vessels. Our standard vessels are rated for steam at 20 psig (1.1.38 bar), 25 psig (1.72 bar), or 30 psig (2.07 bar) dependent upon the customer’s requirements.

SP Hull Lyostar 4

Lowest Shelf Temperature ≤ -70°C
Shelf Temperature Control Range -70 to 60°C
Shelf Temperature Control Range Tolerance ± 0.5°C
Shelf Pull-Down from 25°C to -40°C ≤ 25 minutes
Lowest Condenser Temperature ≤ -85°C
Maximum Condenser Capacity ≥ 30 L
Condenser Surface Area 0.548 m2 (850 in2)
Condenser Pull-Down from 20°C to -45°C ≤ 10 minutes
Number of Compressors 2
Compressor Horsepower (high/ low-stage) 3.5 hp / 2 hp
Vacuum Time to 100 Millitorr ≤ 25 minutes
Vacuum Rate of Rise (per hour) ≤ 40 μbar (30 mT)
Lowest System Vacuum ≤ 13 μbar (10 mT)
Temperature Uniformity ± 1.0°C

Spinco Biotech Pvt Ltd / Spincotech Systems LLP

Spinco Biotech Pvt Ltd / Spincotech Systems LLP
Manufacturer
India

Primary focus area

Analytical Products & Services

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