Medical devices

Medical devices – mixing according to GMP

  Fryma DISHO S 5200 Fryma 1500 Fryma Dynex H 1800 Fryma Dynex H 200 Fryma Dynex 16 CO-1000 Melting Pot MESH 165l DB-1300
Product group Pharmaceuticals
Medical devices
Pharmaceuticals
Medical devices
Pharmaceuticals
Medical devices
Pharmaceuticals
Medical devices
Pharmaceuticals
Medical devices
Pharmaceuticals
Medical devices
Pharmaceuticals
Medical devices
Pharmaceuticals
Medical devices
Usable volume (in L) 400-4’000 200 – 1’300 100-1’500 20-160 05.12.18 200-900 01.10.75 200-1’300
Explosion protection Atex Atex Atex Atex No Atex No Atex
Clean room conditions Class D Class D Class D Class D Class D Class D Class D Class D
Stirring device Anchor stirrer with flow breaker Anchor stirrer and propeller with flow breaker Anchor stirrer with flow breaker Anchor stirrer and propeller with flow breaker Anchor stirrer and propeller with flow breaker Viscojet Propeller Viscojet
Homogeniser Rotor stator No Rotor stator Rotor stator Rotor stator No No No
Products Emulsions, suspensions, gels, solutions Gels, solutions, fatty phase Emulsions, suspensions, gels, solutions Emulsions, suspensions, gels, solutions Emulsions, suspensions, gels, solutions Solutions Suspensions, solutions Suspensions, solutions
Heating / Cooling system Steam and cooling water Steam and cooling water Steam and cooling water Heating up to 100°C
Water circulation
Cooling water approx.. 20°C
Heating and cooling Room temperature Heatable Room temperature
Vacuum / Pressure/ Inertize Vacuum / compressed air,N2 Vacuum / compressed air,N2 Vacuum / compressed air,N2 Vacuum / compressed air,N2 Vacuum / compressed air,N2 No Vacuum / compressed air,N2 Vacuum / compressed air,N2
Location P1 P1 P1 P1 P1 Movable Movable Movable
In operation Yes Yes Yes Yes Q3/2018      

Medical devices – mixing according to NON GMP

  Jumbo and Schneider Stick mixing plant
Moltomat 500

Moltomat 20

Pilot plant
CO-1000
Product group Cosmetics Cosmetics Cosmetics Cosmetics
Perfumes
Cosmetics Cosmetics
Perfumes
Technics
Usable volume (in L) 3’500 150 – 350 150-500 01.10.20 01.01.30 200 – 900
Explosion protection No Atex No No Atex Yes
Clean room conditions n.a. Class F ISO 8 Class D ISO 8 Class F
Stirring device Anchor stirrer with flow breaker Anchor stirrer and propeller with flow breaker Anchor stirrer Anchor stirrer Viscojet Viscojet
Homogeniser Jet stream mixer No Rotor stator Rotor Stator No No
Products Emulsions, suspensions, gels, solutions Gels, solutions, fatty phase Emulsions, suspensions, gels, solutions Emulsions, suspensions, gels, solutions Emulsions, gels, solutions, suspensions Solutions
Heating / cooling system Steam and cooling water Steam and cooling water Steam and cooling water Steam and cooling water Room temperature Room temperature
Vacuum / Pressure / Inertize Vacuum / compressed air,N2 Vacuum / compressed air,N2 Vacuum / compressed air,N2 Vacuum / compressed air,N2 No No
Location Mixing unit Mixing unit Mixing unit Mixing unit Mixing unit Mixing unit
In operation Yes Yes Q3/2018 Q3/2018 Yes Yes

Medical devices – filling and packaging

  Packaging Production Other
  Capacity, size Form and material used Sealing Clean room conditions Capacity No of lines Explosion protection Class of active ingredient Bulk
Aerosol spray Diameter 22 to 66mm, height 52 to 280mm Cylinder made from aluminium, metal sheet, glass 1 inch crimped, 20mm crimped ISO 7 ISO 8 20 to 110 items/min 3 Yes not applicable Liquid
Aerosol mousse Diameter 22 to 66mm, height 52 to 280mm Cylinder made from aluminium, metal sheet, glass 1 inch crimped, 20mm crimped ISO 7 ISO 8 20 to 110 items/min 3 Yes not applicable Liquid
Aerosol crackling Diameter 22 to 66mm, height 52 to 280mm Cylinder made from aluminium, metal sheet, glass 1 inch crimped, 20mm crimped ISO 7 ISO 8 20 to 110 items/min 3 Yes not applicable Liquid
Aerosol foam spray Diameter 22 to 66mm, height 52 to 280mm Cylinder made from aluminium, metal sheet, glass 1 inch crimped, 20mm crimped ISO 7 ISO 8 20 to 110 items/min 3 Yes not applicable Liquid
Aerosol with two compartments Diameter 22 to 66mm, height 52 to 280mm Cylinder made from aluminium, metal sheet, glass 1 inch crimped, 20mm crimped ISO 7 ISO 8 20 to 110 items/min 2 Yes not applicable Liquid
Aerosol multi-compartment Diameter 22 to 66mm, height 52 to 280mm Cylinder made from aluminium, metal sheet, glass 1 inch crimped, 20mm crimped ISO 7 ISO 8 20 to 110 items/min 2 Yes not applicable Liquid
Tubes Diameter 22 to 50mm Polyfoil PE Fuse using heat, pump system ISO 8 ISO 9 20 to 80 items/min 1 No not applicable Liquid to semi-solid
Airless Diameter 22 to 66mm, height 52 to 280mm Cylinder made from aluminium, metal sheet, glass, plastic, polyfoil PE Snap on cap, pump system ISO 7 ISO 8 20 to 80 items/min 2 Yes not applicable Liquid
Plastic bottles Diameter 22 to 66mm, height 52 to 280mm Plastic cylinder Snap on, screw on, crimped cap, pump system ISO 7 ISO 8 20 to 100 items/min 2 Yes not applicable Liquid
Glass bottles Diameter 22 to 66mm, height 52 to 280mm Glass cylinder Snap on, screw on, crimped cap, pump system ISO 7 ISO 8 20 to 100 items/min 2 Yes not applicable Liquid

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