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!!!