Staattisen sähkön aiheuttamat haasteet (ongelmat) lääketeollisuudessa (esim. Easyhaler-kehitys ja tuotanto)

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1 Staattisen sähkön aiheuttamat haasteet (ongelmat) lääketeollisuudessa (esim. Easyhaler-kehitys ja tuotanto) VP Tanninen Formulation Research R&D

2 Tämä STAHAn materiaali on tosi hyvä!

3 Hyötykäyttö staattista sähköä hyödynnetään harvoin lääketeollisuudessa: jauheseoksen homogeenisuus; positiivisesti varattu apuaine ja negatiivisesti varattu vaikuttava aine antoivat parhaan tuloksen (J.Pharm.Sci, Vol p8, No 7, July 2009) varatut inhalaatiopartikkelit; parantamaan keuhkodepositiota jauhepartikkeleiden päällystys materiaalien suodatus, separointi? Yleensä ongelmallinen prosessiongelmat sähköiskut, tarttuminen/valuminen, laiteongelmat, analytikka, punnitseminen, onnettomuudet tulipalot, räjähdykset..

4 Seuraavassa suoria lainauksia ek. seuraavista julkaisuista: Ian Pavey. Static Electricity and the Pharmaceutical Industry, Chemical News, January 2009 ja Ian Pavey: Electrostatic issues associated with EASYHALER Pekka Leskelä: ATEX perusteet ja soveltaminen, Orion koulutus 2008

5 Static electricity costs the pharmaceutical industry dearly measured in terms of production rates, yields, down time in a wide range of operations (e.g. analytics) damage of plant environmental damage injury to personnel

6 Hardly anyone in the process industries is unaware of static electricity and some of the problems it causes electrostatic phenomena are some of the earliest recorded scientific observations yet 4500 years later it is a black art in many respects pharmaceutical industry is particularly vulnerable

7 Legistlation, Standards and Guidelines over next few years EU States will get ATEX 137 employers will be obligated to identify and classify areas where flammable atmospheres could occur sources must be devised detailed knowledge of flammability characteristics of all materials, including ignition sensitivity, will be required plant will have to be designed to safely control the consequences of an explosion

8 Legistlation, Standards and Guidelines alkaen on sovellettava kaikissa EU-maissa Direktiiviä 99/92/ETY (ATEX 137, "USE"-direktiivi), jonka mukaan työnantaja on velvollinen suojaamaan työntekijät räjähdysvaarallisen ympäristön vaaroilta, ja Direktiivä 94/9/ETY (ATEX 95 tai ATEX 100A: "Räjähdysvaarallisissa tiloissa käytettäväksi tarkoitetut laitteet ja suojajärjestelmät, joka käsittelee sähköisiä ja ei-sähköisiä tuotteita, jotka on tarkoitettu käytettäviksi riskialueilla (kaasu-, höyryja/tai pölypitoisessa ympäristössä).

9 Static Charge Generation Tribo-Charging; when two different materials contact one another electrons will move across the interface so that one becomes negatively charged (excess electrons) and the other positively charged Induction Charging: All but the most insulating materials will charge by induction. When exposed to an electric field (such as when the vicinity of a charged object) opposite charges within the material will tend to separate either being attracted towards, or repelled from, the nearby charge. This will leave behind an overall excess of the opposite sign of charge

10 The magnitude of charge the more energetic the process the greater will be the charge generated: Process Sieving 10-3 to 10-5 Pouring 10-1 to 10-3 Scroll Feed Transfer 1 to 10-2 Grinding 1 to 10-1 Micronising 10 2 to 10-1 Pneumatic Transfer 10 3 to 10-1 Charge:Mass ratio (µc/kg)

11 Static Discharges Hazards due to static almost invariably arise because sparks, or discharges, are able to ignite flammable materials Several types of electrostatic discharge have been identified, each with characteristic energies Capacitances and Spark Energies for some common Objects: Object Typical Capacitance (pf) 10 kv Spark Energy (mj) Small metal items Small containers Medium containers Human body Large plant/reaction vessel

12 Static Discharges

13 Explosions

14 Ian Pavey: Electrostatic issues associated with EASYHALER

15 Ian Pavey: Electrostatic issues associated with EASYHALER

16 Ian Pavey: Electrostatic issues associated with EASYHALER

17 Ian Pavey: Electrostatic issues associated with EASYHALER

18 Ian Pavey: Electrostatic issues associated with EASYHALER

19 Ian Pavey: Electrostatic issues associated with EASYHALER

20 Ian Pavey: Electrostatic issues associated with EASYHALER