John Morris Scientific Service plus Solutions

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2 John Freeze Dryers For Every Application Selecting the right freeze dryer for your needs: 1. Select the application as to how it will be used: Routine: Entry level control system () for day-to-day freeze drying applications Advanced: For more advanced/critical freeze drying applications () such as pharmaceutical, environmental & microbiology Pilot: Offer the same benefits as Advanced yet more suited for clinical trial phase, small batch production and production R&D applications - TGA/FDA validation packages available Production: Processing pharmaceutical and biotech products or use in industrial applications - we are able to customise solutions to meet your needs (plus install and train your staff) 2. Decide the type of product to be dried - Aqueous or Solvent (Organic/Inorganic) 3. Choose the Ice Condenser Capacity of product to be frozen Routine Advanced Pilot Production Ice Condenser Capacity 2 kg 4 kg 6 kg 8 kg 10 kg 16 kg 24 kg 20 - >1,000 kg Aqueous Alpha 1-2 Alpha 1-4 Beta 1-8 Solvent Aqueous Solvent Solvent Solvent Alpha 2-4 Beta 2-8 Alpha 1-4 Beta 1-8 Gamma 1-16 Delta 1-24 Alpha 2-4 Beta 2-8 Gamma 2-16 Delta 2-24 Epsilon 2-6 Epsilon 2-10 Customised solutions also provides specialised pumps designed for each type of product to be dried: Aqueous Products Vacuubrand RZ6 Rotary Vane Pump High water vapour load tolerance - ideal for freeze drying Large oil volume (long intervals between oil changes) Ultimate vacuum of 2x10-3 mbar Pumping speed of 5.7 m 3 /hr Solvent Products Vacuubrand RC6 Hybrid Pump Unparalleled corrosive vapour resistance (due to unique chemistry diaphragm & rotary vane pump combination) High water vapour load tolerance - ideal for freeze drying Oil changes reduced by 90% Ultimate vacuum of 2x10-3 mbar Pumping speed of 5.9 m 3 /hr also has a wide selection of Vacuubrand pumps 2

3 Routine Applications () Alpha 1-2 Alpha 1-4 Alpha 2-4 Beta 1-8 Beta 2-8 Entry level control system () for day-to-day freeze drying applications. Specifications Ice Condenser Capacity 2.5 kg 4 kg 8 kg Ice Condenser Performance 2 kg/24 hour 4 kg/24 hour 6 kg/24 hour Ice Condenser Temp Aqueous -55ᵒC (Alpha 1-2) -55ᵒC (Alpha 1-4) -55ᵒC (Beta 1-8) Solvent - -85ᵒC (Alpha 2-4) -85ᵒC (Beta 2-8) Product Temperature (Inside Ice Condenser) Aqueous -25ᵒC (Alpha 1-2) -25ᵒC (Alpha 1-4) -25ᵒC (Beta 1-8) Solvent - -50ᵒC (Alpha 2-4) -50ᵒC (Beta 2-8) Product Shelves Drying Outside Ice Condenser 3 Shelves 5 Shelves 5 Shelves ø 200 mm ø 360 mm ø 360 mm 920 cm m m 2 Drying in Injection Vials with Stoppering 2 Shelves 4 Shelves 4 Shelves ø 200 mm ø 250 mm ø 250 mm 557 cm m m 2 Drying in Round Bottom Flasks (max) 8 Pieces 24 Pieces 24 Pieces Base Unit Dimensions W x H x D (mm) 315 x 345 x x 415 x x 415 x 545 Weight Aqueous 28 kg (Alpha 1-2) 42 kg (Alpha 1-4) 63 kg (Beta 1-8) (excluding chamber) Solvent - 65 kg (Alpha 2-4) 78 kg (Beta 2-8) Electrical Connection 230 V; 50 Hz 230 V; 50 Hz 230 V; 50 Hz Chamber Configuration Options (more options & accessories are available to meet your specific product drying requirements) Base unit + 3 shelves & 8 ports Base unit + stoppering device, 2 shelves & 8 ports Base unit + 5 shelves Base unit + 3 shelves, 8 ports & drip tray Base unit + 5 shelves Base unit + 3 shelves & 24 ports Base unit + stoppering device, 2 shelves & 8 ports Base unit + 3 shelves & 12 ports Base unit + 5 shelves To ensure you select the right freeze dryer for your needs, simply contact for professional assistance. Base unit + 8 ports Base unit +ampoule manifold Base unit + 3 shelves & 24 ports 3

4 John Advanced Applications () Alpha 1-4 Alpha 2-4 Beta 1-8 Beta 2-8 Gamma 1-16 Gamma 2-16 Delta 1-24 Delta 2-24 For more advanced/critical freeze drying applications () such as pharmaceutical, environmental & microbiology - refer page 7 for the benefits of. Specifications Base unit + 5 heated shelves + 12 ports Base unit + manifold for 8 ports Base unit + 2 drying chambers Base unit + stoppering device & 4 heated shelves Ice Condenser Capacity 4 kg 8 kg 16 kg 24 kg Performance 4 kg/24 hour 6 kg/24 hour 12 kg/24 hour 18 kg/24 hour Temp Aqueous -55ᵒC (Alpha 1-4) -55ᵒC (Beta 1-8) -55ᵒC (Gamma 1-16) -55ᵒC (Delta 1-24) Solvent -85ᵒC (Alpha 2-4) -85ᵒC (Beta 2-8) -85ᵒC (Gamma 2-16) -85ᵒC (Delta 2-24) Chamber Volume 6.5 L 11 L 30 L 45 L Temp Inside Condenser Aqueous -25ᵒC (Alpha 1-4) -25ᵒC (Beta 1-8) -40ᵒC (Gamma 1-16) -40ᵒC (Delta 1-24) Solvent -35ᵒC (Alpha 2-4) -35ᵒC (Beta 2-8) -50ᵒC (Gamma 2-16) -50ᵒC (Delta 2-24) Product Shelves Inside Condenser & 1 shelf 1 shelf 5 shelves 10 shelves Single Chamber (max) ø 200 mm ø 200 mm ø 200 mm ø 200 mm m m m m 2 Vials Inside Condenser 1 shelf 1 shelf 2 shelves 4 shelves with Stoppering & ø 200 mm ø 200 mm ø 200 mm ø 250 mm Single Chamber (max) m m m m 2 Outside Condenser & 10 shelves 10 shelves 10 shelves 10 shelves Double Chamber (max) ø 200 mm ø 200 mm ø 200 mm ø 200 mm m m m m 2 Vials Outside Condenser 4 shelves 4 shelves 4 shelves 4 shelves with Stoppering & ø 250 mm ø 250 mm ø 250 mm ø 250 mm Double Chamber (max) 0.18 m m m m 2 Drying in Round Bottom Flasks or Wide Neck 12/24 Pieces 12/24 Pieces 12/24 Pieces 12/24/36 Pieces Filter Bottles Base Unit Dimensions W x H x D (mm) 390 x 415 x x 415 x x 485 x x 1050 x 650 Weight Aqueous 48 kg (Alpha 1-4) 63 kg (Beta 1-8) 135 kg (Gamma 1-16) 215 kg (Delta 1-24) (excluding chamber) Solvent 60 kg (Alpha 2-4) 78 kg (Beta 2-8) 160 kg (Gamma 2-16) 250 kg (Delta 2-24) Electrical Connection 230 V; 50 Hz 230 V; 50 Hz 230 V; 50 Hz 3 X 400 V; 50 Hz Chamber Configuration Options (more options & accessories are available to meet your specific product drying requirements) Base unit + LyoCube 4-8 (5 heated shelves) Base unit + LyoCube 4-8 (5 heated shelves) Base unit + stoppering device & 2 heated shelves Base unit + 2 drying chambers & 24 ports To ensure you select the right freeze dryer for your needs, simply contact for professional assistance. Base unit + manifold for 20 ports Base unit + stoppering device & 5 heated shelves Base unit + 5 heated shelves Base unit + 10 heated shelves & 12 ports 4

5 LyoCube 4-8 Fast front loading chamber avoids sample melting Configuration option compatible with Alpha 1/2-4 & Beta 1/2-8 Massive shelf area up to 0.61m 2 Heated shelves with Wireless Shelf Technology (faster drying time & no cable connections) One temperature or LyoRx sensor per shelf for optimum process control Specifications Chamber Volume 58 L Chamber Dimensions - Inner (mm) W: 336 D: 370 H: 426 Shelf Dimensions (mm) W: 256 D: 300 H: 18 Weight 47 kg Shelf Options (with MPT or Deep-Well Plates) Usable Total Distance Shelves Shelf Area Between Shelves 1 Shelf 0.08 m mm 2 Shelves 0.15 m mm 3 Shelves 0.23 m mm 4 Shelves 0.31 m mm 5 Shelves 0.38 m mm 6 Shelves 0.46 m mm 7 Shelves 0.54 m mm 8 Shelves 0.61 m mm Unique Wireless Heated Shelving Alpha 1-4 with LyoCube 4-8 (5 heated shelves) 5 heated shelves (more options available) Up to 65% saving in drying time via unique Wireless Shelf Technology (no cables) Configuration option compatible with all Alpha, Beta, Gamma & Delta units Temperature of each shelf is individually controlled (± 1ᵒ Kelvin) Chart illustrating the drying time of pure water saved using heated shelves v s unheated shelves 5

6 John Pilot Applications Epsilon 2-6D 2-10D Pre-freezing on liquid-controlled shelves Freeze drying according to pre-selected desired time, temperature & pressure limits Validation packages available for TGA/FDA guidelines Large range of process optimisation tools H 2 O 2 decontamination & isolator options Specifications Ice Condenser Capacity 6 kg 10 kg Performance 4 kg/24 hour 8 kg/24 hour Temperature -85ᵒC -85ᵒC Chamber Volume 23 L 25 L Shelf Temperature -50ᵒC to + 60ᵒC -55ᵒC to + 60ᵒC Shelf Temperature Accuracy ± 1ᵒC ± 1ᵒC Outside Unit Dimensions (mm) 860 (W) 650 (D) 1267 (H) 1190 (W) 850 (D) 1295 (H) Drying Chamber Dimensions (mm) 320 (W) 335 (D) 320 (H) 470 (W) 470 (D) 460 (H) Shelf Dimensions (mm) 225 (W) 300 (D) 350 (W) 400 (D) Weight 330 kg 750 kg Shelves Up to 6+1 Up to 7+1 Production Applications Ice condenser capacities from 20 to > 1000 kg Single or double chamber systems Freezing & drying in the drying chamber SIP/H 2 O 2 disinfection, CIP, IQ/OQ, etc Process integration (loading systems, peripheral equipment) We can design custom-build systems to meet your needs - plus install & provide training for your staff Accessories also supplies an extensive range of accessories & spare parts. Repairs & Maintenance In addition, our Instrument Services Division provides routine maintenance & repairs to keep your equipment operating to its optimum performance. To ensure you select the right freeze dryer for your needs, simply contact for professional assistance. 6

7 Benefits of Applications Control System Display Vacuum Control Product Temperature Measurement Freezing Point Determination Pressure Increase Test Comparative Pressure Measurement Advanced freeze dryers for research & development applications (4-24 kg) Freeze dryers for routine laboratory use (2-8 kg) Colour touch-screen control (automatic or manual sequencing) Graphical diagram of the freeze drying process Selection of different product switching conditions (temperature, resistance, pressure increase test, etc) Storage for up to 32 user-defined programs (optional) Graphic LC display showing the most important process data Vacuum control for optimisation/reduction of process times Conversion of product temperature & vacuum according to the vapour pressure curve above ice The vacuum pressure within a freeze dryer determines the product temperature (vacuum control is essential to keep the product frozen while limiting the amount of vapour produced) - included As per above (optional) Direct - every shelf can be equipped with a PT-100 sensor to measure the product temperature directly Indirect - converts vacuum into product temperature LyoRx sensor measures temperature & electrical resistance simultaneously - resulting data can be utilised for the automatic determination of product freezing point. - Automatically determines the end of drying cycle - isolation of ice condenser & drying chamber (optional) - Uses Pirani & Capacitive vacuum sensors to determine end of main drying phase - when the difference of the pressure measurement falls below a pre-defined limit, the secondary drying phase automatically starts (optional) - Freezing & Drying (Single Chamber - Inside) In this configuration, the product is frozen & then dried inside the ice condenser chamber This method is particularly suitable for substances with a low freezing point or for thermolabile substances Freezing assisted by a fan (optional) - Drying Only (Double Chamber - Outside) In this configuration, the product is pre-frozen separately & then dried above the ice condenser chamber This method enables the use of a large variety of accessories An intermediate valve can be used to seal the product chamber against the ice condenser chamber for a pressure increase test Software As per above (except pressure increase test) Windows based software to control, store recipes & record process parameters (LPCplus) - complies with current GAMP/CFR Part 11 guidelines, LyoLog plus USB data logging (optional) Windows based software to record process parameters (LyoLog plus) (optional) 7

8 At we offer more than just the product - we provide the full package - sales and servicing of instrumentation plus design tailored solutions to meet your needs. John Head Office Address Victoria Avenue Chatswood NSW 2067 Australia Free Call Enquiries +61 (0) info@johnmorris.com.au Web PROUDLY AUSTRALIAN For Over 50 Years

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