Safe handling of pharmaceutical dust

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Ezra Hensley
6 years ago
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1 Safe handling of pharmaceutical dust Herding Filtertechnik offers the complete filtration package Herding GmbH Filtertechnik Amberg, Germany Stand:

2 The Herding Pharma-concept De-dusting in the pharmaceutical industry Examples for units used for the extraction of different process steps at the production of pills Dust Separation and filtration quality Low-contamination dust disposal SafeChange for filter elements exchange Dust properties ATEX and secondary or tertiary measurements, Dust Zone barrier Compact filter with individual equipment options Market approach, Summary and perspectives 2

3 De-dusting in the pharmaceutical industry Dusts are generated during the solida production processes: Weighing transport mixing agglomeration drying sieving dosing pelletizing coating - packing The pharmaceutical industry demands filter units to: keep high potent dusts enclosed separate dusts on finest filter surfaces handle explosible dusts safely 3

discharge in Mixing Container Sieving station BTS Mixing

4 Production process Weighing in Mixing Container Load via vacuum at Granumator Granulating and drying in GMAsystem Dust-free discharge in Mixing Container Sieving station BTS Mixing Filling of pelleting-press Filling of Coater Coating Discharge with BET 4

5 Containment-Systematic 5

6 OEB/OEL Pyramid Insulator systems Protection foil systems SoliValve Open Systems Extreme poisenous High poisenous Poisenous Limited poisenous Almost nonpoisenous nonpoisenous OEB Occupational Exposure Band OEL Occupational Exposure Limit WG - Potency 6

7 Dust characteristics particle size < 1 µm dry fibrous sticky conductive hydrophobic inflammable dangerous to health bulk density particle shape agglomerating abrasive containing oil electric changeable hygroscopic potentially explosive toxic dust quantity 7

Components of HSL filter element stainless steel bar to stabilise filter element and support the system DUPLEX-gasket specially designed to reliably separate raw gas from clean gas

large area of 0,25 to 7,6 m² compact rigid structure to cope with abrasive and extremely fine dusts PTFE-coating is embedded in pores of PE matrix to form a microporous surface

8 Components of HSL filter element stainless steel bar to stabilise filter element and support the system DUPLEX-gasket specially designed to reliably separate raw gas from clean gas filter element capable of being washed, regenerated, recycled, lint free body material consisting of seamlessly sintered PE corners good cleaning performance filter area relatively large area of 0,25 to 7,6 m² compact rigid structure to cope with abrasive and extremely fine dusts PTFE-coating is embedded in pores of PE matrix to form a microporous surface hollow space enlarged for reduced pressure drop reinforcement to stabilise and locate filter element high degree of separation approved and certified extremely long service life stiff body 8

9 Filter element approved and certified separation efficiency for use for dust class M (DIN EN ) approved and certified separation efficiency as HEPA filter rated class R (DIN ) comparable to HEPA H11 (EN 1822) approved and certified antistatic version surface resistance < 10 9 Ohm and leakage resistance < 10 8 Ohm (BGR 132 Avoiding of ignition dangers due to electrostatic charging ) approved and certified non-chargeable design (DIN EN Part 1 amendment C) approved and certified flame barrier for dust explosions (VDI 2263 Part 3, Certificate 2310/206/99 BVS-Fa) approved and certified Dust Ex Zone barrier for dust explosions (ATEX 94/9/EG, explosion protection guideline ExVO) approved and certified GMP conform design (Guideline 90/128/EWG, according food and utility law) 9

10 Filter element Categorie H Dust classes according EN amendment AA Prüfmittel Staubklasse Verwendungszweck max. Durchlassgrad Quarzstaub L Stäube mit MAK-Werte > 1 mg/m³ 1,0 % M Stäube mit MAK-Werte 0,1 mg/m³ 0,10 % Aerosol H Stäube mit MAK-Werte, krebserregende Stäube sowie Stäub mit Krankheitserregern 0,005 % during three measuring runs the penetration level was 0,00068%. This is below the maximum allowed dust penetration level required for cancerogen dusts of 0,005%. the filtration quality is comparable with the class H11 10

11 Filter units with second filter stage HEPA- Filter mounted aside HEPA- Filter integrated HEPA- Filter mounted on outlet 11

Process technique Separating the process At agglomeration, drying and coating processes with water based or organic solvents separate - Agglomerating-, drying- and heating period from -

12 Process technique Separating the process At agglomeration, drying and coating processes with water based or organic solvents separate - Agglomerating-, drying- and heating period from - spraying period (this means no Jet-Puls-Cleaning of the dusts during the spraying period) The protective measurement Avoiding effective ignition sources proves to be sufficient for most applications 12

13 Handling of explosive dusts according VDI 3673 Pressure relief of dust explosions 13

14 Explosion suppression according VDI 2263 Part 4 Suppression of dust explosions - Installation in working rooms - for toxic dusts 14

15 PharmEx Filter 15

Herding HSL-PharmEx Filter expansion space (clean gas room) control panel cleaning device raw gas room with HSL-elements raw gas inlet (back) secondary filter with HEPA-filter H13 clean gas outlet

16 Herding HSL-PharmEx Filter expansion space (clean gas room) control panel cleaning device raw gas room with HSL-elements raw gas inlet (back) secondary filter with HEPA-filter H13 clean gas outlet Separation organic dusts K ST -Value up to 300 bar m/s foot height according to dust disposal system interface for different dust collecting systems (optional) Max. explosion pressure 10 bar Pressure in Filter unit < 0.7 bar 16

Alternative to 2-stage filter unit Two stages necessary WIP not possible SafeChange necessary, because of life time No rigid body filter element No second stage necessary WIP

17 Alternative to 2-stage filter unit Two stages necessary WIP not possible SafeChange necessary, because of life time No rigid body filter element No second stage necessary WIP possible Proven life time of 13 years, expectably more Rigid body filter No zone barrier Dust zone barrier High separation efficiency no need for change of downstream installed HEPA-filter 17

18 Adhesive dusts Use of Pre-coating devices for very sticky dusts after fluid bed coaters for example for Acryl-resin (EUDRAGIT ) 18

19 Adhesive dusts Complete filter system 19

20 De-dusting from strongly adhesive products Silo for precoat material Dust disposal drum Precoater for building filter auxiliary layer 20

21 First Rinse Dust-loaded, raw gas compartment contaminated Dust-loaded raw gas compartment in the area of the spray lances Raw gas compartment after washing Spray lances after washing View of the hopper from above 21

22 SafeChange for the exchange of filter elements 22

23 Low-contamination dust disposal mechanical pneumatically continuous lining Pneumatical dust discharge to the external dust disposal pneumatical dust discharge 23

24 Central exhaustion system Central de-dusting system With side channel blower (compression: 225 mbar) Air flow 500 Am³/h Dust discharge via flap and dust bin 24

Dust disposal without contamination A = Housing B =

into the raw gas duct 1 = Police filter with connection

Sinterplate filter elements 4 = Liner 5 = Welding frame

25 Dust disposal without contamination A = Housing B = Negative pressure inside the housing created by suction into the raw gas duct 1 = Police filter with connection to the suction system 2 = Filter housing 3 = Herding Sinterplate filter elements 4 = Liner 5 = Welding frame 6 = Fibre-Drum 7 = scale for monitoring of filling level 25

26 Central dust disposal Pneumatic dust discharge out of different filter plants Details from Continuous-Liner- System 26

27 Welding of plastic bag for dust disposal welding systematic Separation weld

28 Central de-dusting system modernisation Filter system with low pressure level dedusting and vacuuming 28

29 Central and no contamination dust disposal Central dust disposal plant Dust discharge in Continuous- Liner-System 29

30 Summary Production Process for solida known Filter units for different production processes available mainly technical area and not integrated in Coater Certified filtermedia available (and GMP design possible) Dust disposal systems up to no contamination SafeChange of filter media Sticky dust after coater can be handled by pre-coating (no product recovery in pharma process) Explosive dust can be handled PharmEx- Filter tested Central dust disposal system reduces costs an contamination risk PharmEx filter unit by explosive dusts Filtration additive by film coating Minimized filter change and contamination free Contamination free dust disposal No filter change no contamination risk 30

31 Thank you for your attention Herding GmbH Filtertechnik Amberg, Germany

Profile of an innovative company

Profile of an innovative company. August-Borsig-Str. 3 92224 Amberg/Germany Phone: +49(0)9621 630-0 Website: www.herding.com E-mail: info@herding.de Herding Filtertechnik: pure productivity For clean air,