PHARMA - Senze-Instruments Benelux

Senze-Instruments BENELUX
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Process & Quality Control

PHARMA

Coatings & Industry > Corrosion + Ageing > Climatic Chamber
 
Chambers for COOLING & FREEZING to store Pharmaceutical Product

The U.S. Food and Drug Administration (FDA) recommends the following for refrigerated and food storage.      
  • Keep the refrigerator temperature at or below 4°.
  • The freezer temperature should be -18° C.

For this reason we have in our manufacturing plan, modular and walkin equipment or compact systems with lower load capacity.
We have equipment with forced air circulation and cooling by static evaporation.

Climatic chambers for stability tests acc. with "guidelines  ICH/FDA"
In general cases, products and pharmaceutical substances should be tested under the following conditions :
  • Long Term Study : 25°C/60% RH (minimum 12 months)
  • Long Middle-term Study : 30°C/65% RH (minimum 6 months)
  • Accelerated Study : 40°C/75% RH (minimum 6 months)

For substances or pharmceuticals in semi-permeable packaging, the test conditions have been set out under the following guidelines :
  • Long Term Study : 25°C/40% RH (minimum 12 months)
  • Long Term Study : 40°C/25% RH (minimum 12 months)

During these tests yous should ensure a deviation of temperature +/-2°C and in relative humidity of +/-5%RH
CM  ICH series

Design within the requirements of the guidelines ICH Q1A and Q1B, vertical cabinets facilitates the  storage of large batch samples.
Easy to integrate within laboratories with small space.

Optional elements :
  • IQ, OQ and PQ documentation
  • Additional shelves
  • Tempered glass doors
  • Touch screen panels
  • Reservoir of 80 liters water                    

Features :
  • Volumes: 600 or 1.200 liters
  • Temperature range: +10ºC till +50ºC
  • Humidity range: From 50% to 90% RH.
  • Temperature Stability: ±0,1 ºC to ±0,5ºC
  • Temperature Uniformity: ±0,5 ºC to ±1,5ºC
  • Humidity stability: ±1%RH
  • Humidity Uniformity: ±1%RH to ±3%RH
Compact Climatic chambers

PHARMACEUTICAL STABILITY CM  
4 Standards temperature range :
  • 0°C,
  • -25°C,
  • -40°C and
  • -70°Cq to +180°C
Humidification System with range from 10°C to 98%RH
Wide range of abilities useful interior from 48 liters to 2500 liters
Observation windows
Acces port for sensors
Height adjustables shelves
Extremely robust construction (monoblock, structure of zinc coated steel, with oven cured acrylic paint RAL 9010
Interior in AISI 304 stainless steel sheet
Thermal insulation consisting of semi-rigid polyurethane foam of high density
Walk-In  Taylor Made Chambers
CMm Series

The chambers are standardized or "turnkey" systems to suit the customer preference adaptating the interior volume or the external dimensions to the existing space.
The capacity of these chambers can go from 700 liters to 300.000 liters.
With great stability environmental conditions are set to ranges of temperature between +10°C and +50°C, with humidity between 50 and 90. % RH.
PHARMACEUTICAL STABILITY. CM ICH SERIES
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CM ICH series has an accuracy temperature and humidity control in order to ensure stability parameters of these variables according with the directive ICH Q1A (R2) Stability Testing of New Drug Substances and Products and US FDA 21 CFR part 11.
These equipments comply with the three studies in those directives: large and middle duration or accelerated.
It’s possible to adapt the chamber the chamber for the photostability test according with the directive: ICH Q1B Photostability Testing of New Drug Substances and Products, option 2.
Our laboratory, LCIS, is the responsible to do the qualification of the chambers: DQ, IQ, OQ or PQ.

Features:
  • Volumes: 600 or 1.200 liters
  • Temperature range: +10ºC till +50ºC
  • Humidity range: From 50% to 90% RH.
  • Temperature Stability: ±0,1 ºC to ±0,5ºC
  • Temperature Uniformity: ±0,5 ºC to ±1,5ºC
  • Humidity stability: ±1%RH
  • Humidity Uniformity: ±1%RH to ±3%RH
Standard:
– High accuracy double regulator to control temperature and humidity.
– Methacrylate box with safety key to avoid manipulation.
– High precision temperature probe and humidity capacitive sensor.
– Interior and exterior made in Stainless Steel AISI 304.
– Lock with key in door.
– Magnetic weather-strip.
– Shelves (4 in 600 liters model and 8 in 1200 liters model)
– 80 mm Access-ports.
– Height adjustable legs or casters.
– Air cooled condenser unit.

Optional:
– Control by microprocessor DYCOMETAL’s ACTTA, with touch screen panel.
– Water reservoir tank (80 liters)).
– Illumination lights for photostability tests.
– Different temperature range.
– Door with glass and Interior light.
– 4 Casters.
– Additional shelves.
– Lacquered exterior.
– Water demineralization system.
– DQ, IQ, OQ, PQ Certification.
CM Series

Features:

• Volumes:                             From 48 to 2.500 liters
• Temperature range:          -70ºC, -40ºC, -25ºC or 0ºC to +180ºC
• Humidity range:                 From 10% to 98% RH.
• Temperature Stability:       ±0,1 ºC to ±0,3ºC
• Temperature Uniformity: ±0,5 ºC to ±1,5ºC
• Humidity stability:             ±1%RH
• Humidity Uniformity:       ±1%RH to ±3%RH
Standard:

– Control by microprocessor with automatic and precise adjustment.
– High precision temperature probe and humidity capacitive sensor.
– Observation window.
– Interior light.
– 80 mm Access-port.
– 2 Stainless steel shelves
– Alarms management system.
– Height adjustable legs or casters (depending on models).
– RS-232 Communication port.
– Remote control Software.
– Automata for fault management with display screen by messages.
– Condenser unit: air or water cooled.
Optional:

– Control by microprocessor DYCOMETAL’s ACTTA, with touch screen panel.
– Additional access ports of different diameters
– Reinforced floor.
– Additional shelves.
– Cryogenic valve for injection of liquid nitrogen
– Lateral access for conditioning an external unit
– I/O digital or analog for events.
– Compressed air drier for reduce the humidity levels, increasing the dew point range.
– Additional sensor to control the temperature on samples
– Sun simulation system
– Water reservoir tank (80 liters).
– Water demineralization system.
– Data Logger
- Chambers with 1/2/3/4 horizontal compartments
-Chambers with 2 vertical compartments
MODULAR CLIMATIC CHAMBERS.   
Walk-in chambers
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When the components to be tested have big dimensions, the number of samples are a lot or the weight are high, it’s necessary the use of Walk-in chambers.
These chambers will be manufactured by insulated panels (modular chambers), for a temperature range at maximum +90ºC.
Our new MODUBLOCK format allows the transport of the modular chamber by a forklift. Its volumes can be from 700 to more than 10.000 liters.
Applications: electronic, automotive, pharmaceutical, plant growth, etc.
Features:
• Volumes: From 700 to more than 300.000 liters
• Temperature range: -70ºC, -40ºC, -25ºC or 0ºC to +85ºC
• Humidity range: From 20% to 98% RH.
• Temperature Stability: ±0,1 ºC to ±0,5ºC
• Temperature Uniformity: ±0,5 ºC to ±1,5ºC
• Humidity stability: ±1%RH
• Humidity Uniformity: ±1%RH to ±3%RH
Standard:
– High accuracy double regulator to control temperature and humidity.
– High density insulation.
– Different interior finished: lacquered or stainless steel.
– Exterior: lacquered or stainless steel.
– Access door: 1800 x 850 mm.
– Lock door with key.
– Internal door aperture system.
– Observation window.
– Safety elements.
– Access port, 80 mm.
– High precision temperature probe and humidity capacitive sensor.
– Interior light.
– Cooling group manufactured with housing. It can be placed over the chamber, on the ceiling of the room or in the
    machine room.
– Troubleshooting management Automat.
Optional:
– Control by microprocessor DYCOMETAL’s ACTTA, with touch screen panel.
– Extended temperature range (SOLID WALK-IN)
– MODUBLOCK structure, to move the chamber.
– Health profiles.
– Plant growth light systems.
– Sun simulation light systems.
– Custom doors with special aperture: Pivoting double door, sliding, guillotine, etc
– Gases control.
– Compressed air drier for reduce the humidity levels, increasing the dew point range.
– Shelves with different height levels: polypropylene or stainless steel trays.
– Additional access ports.
– Water demineralization system.
– Data loggers: paper or Paperless Graphic Recorder
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