The importance of HUMIDITY CONTROL in Pharmaceutical Industries Belén Sampedro Business 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 Sorption dehumidifiers Mechanical dehumidifiers (cooling +heating)

DFRA SERIES

WHY SORPTION 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

COMBINED SYSTEMS FRESH AIR HEATING COIL COOLING COIL 16 g/kg FRESH AIR 30ºC and 60%RH 8,5 g/kg HEATING COIL 25ºC and 40%RH COOLING COIL 11ºC and 98%RH Dessicant DEHUMIDIFIER 32ºC and 12%RH <3,5 g/kg <3,5 g/kg

PHARMA INDUSTRY APPLICATIONS PHARMACEUTICAL INDUSTRY Clean rooms and Laboratories These industries require air humidity high precision control References: Boehringer Ingelheim, Bristol Myers Squibb, GSK, Normon, Lilly, Pfizer, Pharma Mar, Roche, Bayer, Sanofi Aventis, Schering-Plough, Wyeth, C.S.I.C., SGS.

Application: BLISTERING 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: 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

REAL CASE CALCULATION 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)

INFILTRATIONS scheme Supply air: 1,9 g/kg to absorve the infiltrations Corridor 22ºC / 60%RH 10,78 g/kg CLEAN ROOM Area num.4 21ºC / 15%RH / 2,5 g/kg Infiltrations from the corridor 9,541 Kg/h Extraction 1500 m3/h

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 DEHUMIDIFIER: Fresh air+ recirculating air drying

Thank you!!!