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The importance of HUMIDITY CONTROL in
Pharmaceutical Industries
Belén SampedroBusiness Developer
THE IMPORTANCE OF HUMIDITY CONTROL
The lack of humidity control affects:
• Comfort: Environmental Wellness
• Health: Respiratory diseases, viruses, bacteria, allergies, etc.
• Materials: Hygroscopic and corrosion.
• Static Electricity: Risk for materials and people. Discomfort.
DRYING SYSTEMS
Mechanical dehumidifiers (cooling +heating)
Sorption dehumidifiers
DFRA SERIES
• To reach dew points <10ºC
• To reach Absolute humidity points < 8,5 g/kg
• Desiccant dehumidification is more efficient at low relative humidity and temperature , and it’s cheaper than mechanical dehumidification a DBT<20ºC
• The best option and when both systems works better is by combining the mechanical (first step) and desiccant (second step)
• Most cases, the choice is not an easy decission. Energy cost will be the key factor
WHY SORPTION
16 g/kg
8,5 g/kg
<3,5 g/kg
FRESH AIR30ºC and 60%RH
HEATING COIL25ºC and 40%RH
Dessicant DEHUMIDIFIER32ºC and 12%RH <3,5 g/kg
COOLING COIL11ºC and 98%RH
COMBINED SYSTEMS
PHARMACEUTICAL INDUSTRYClean rooms and Laboratories
These industries require air humidity high precision control
PHARMA INDUSTRY APPLICATIONS
References:Boehringer Ingelheim, Bristol Myers Squibb, GSK, Normon, Lilly, Pfizer, Pharma Mar, Roche, Bayer, Sanofi Aventis, Schering-Plough, Wyeth, C.S.I.C., SGS.
REQUIRED CONDITIONS: 22ºC, 30%HR, 4,9 g/kg
Why do we need DRY AIR?
• To avoid the product absorves humidity
• To avoid condensation and microbiological problems in the storage
• To Increase blistering speed (more production)
• To decrease the number of maintenance interruptions
• Direct dry air inside the blistering cabinet (smaller size of the dehumidifier)
Application: BLISTERING
Application: STERILE AREA
REQUIRED CONDITIONS: 22ºC, from 10% to 30%HR (1,6 - 4,9 g/kg)
Why do we need DRY AIR?
• To avoid the product absorves humidity
• To avoid microbiological growth when low humidity
• Dry air mixed before the AHU
Application: GELATINE CAPSULES
REQUIRED CONDITIONS: 22ºC, from 4% to 10%HR (0,6 - 1,6 g/kg)
Why do we need DRY AIR?
• To dry the gelatine capsules
• To decrease non-quality products
• Direct dry air inside the cabinet
• To Increase drying process,more production
Application: ACCELA COTA MACHINE
REQUIRED CONDITIONS: 22ºC, 4%HR (0,6 g/kg)
Why do we need DRY AIR?
• To help coating the product
• To increase speed of production
• To decrease the dosage of powder coating
• To increase stability / product quality giving greater hardness
• To increase the hygienic quality of the product
• Direct dry air inside the coating pan
Application: PILLS PRODUCTION
REQUIRED CONDITIONS: 22ºC, from 30%HR
Why do we need DRY AIR?
• To avoid condensation on the product
• To ensure continuous production
• To decrease non-quality products
• To decrease the number of maintenance interruptions
• Direct dry air inside the cabinet
Application: FLUIDIZED BED
REQUIRED CONDITIONS: 45ºC-60ºC, 5%HR
Why do we need DRY AIR?
• To avoid fresh air (different) conditions
dependence
• To stabilize production times
• Allows to increase the temperature of dry
air without quality product change
• To decrease the cicle time, increasing the
capacity up to 20%
• Direct dry air inside the the fluidized bed
in parallel flux
• Air handling project in a Pharma Lab production area , Madrid.
• Outdoor air conditions T= 34ºC, RH= 43%, X= 15,68 g/kg
• Room set poin, design T= 21ºC, RH= 15%, X= 2,5 g/kg
• Corridor air conditons T= 22ºC, RH= 60%, X= 10,78 g/kg
• Three persons working in the room• No loads due to product lost in weight• Negative pressure from the corridor (infiltrations)
REAL CASE CALCULATION
Corridor 22ºC / 60%RH
10,78 g/kgCLEAN ROOM
Area num.421ºC / 15%RH / 2,5 g/kg
Infiltrations from the corridor
9,541 Kg/h
INFILTRATIONS scheme
Supply air: 1,9 g/kg to absorve the infiltrations
Extraction
1500 m3/h
DEHUMIDIFIER: Fresh air+ recirculating air drying
INSTALLATION REQUESTS
Internal humidity loads to be absorved 9,5 kg/h + fresh air loads 9 kg/h = TOTAL LOADS to absorve 18,5 kg/h
Thank you!!!