Safe handling of pharmaceutical dust - Indpro · Safe handling of pharmaceutical dust Herding®...
Transcript of Safe handling of pharmaceutical dust - Indpro · Safe handling of pharmaceutical dust Herding®...
© 2009 Pharmaceutical Industry
Safe handling of pharmaceutical dust
Herding® Filtertechnik offers the complete
filtration package
Herding GmbH Filtertechnik
Amberg, Germany www.herding.de
Stand: 10.08.10
© 2009
2 Pharmaceutical Industry
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
The Herding® Pharma-concept
© 2009
3 Pharmaceutical Industry
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
© 2009
4 Pharmaceutical Industry
Production process
Mixing
Weighing in Mixing
Container
Load via vacuum
at Granumator
Granulating and
drying in GMA-
system
Dust-free
discharge in
Mixing Container
Sieving station
BTS
Filling of Coater Coating Filling of pelleting-press
Discharge with BET
© 2009
6 Pharmaceutical Industry
OEB/OEL Pyramid
Insulator systems
Protection foil systems
SoliValve®
Open Systems
OEB – Occupational Exposure Band OEL – Occupational Exposure Limit WG - Potency
Extreme poisenous
High poisenous
Poisenous
Limited
poisenous
Almost
nonpoisenous
nonpoisenous
© 2009
7 Pharmaceutical Industry
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
© 2009
8 Pharmaceutical Industry
DUPLEX-gasket specially designed to
reliably separate raw
gas from clean gas
stainless steel bar to stabilise filter element
and support the system
filter element capable of being washed,
regenerated, recycled, lint free
hollow space enlarged for reduced
pressure drop
PTFE-coating is embedded in pores of
PE matrix to form a
microporous surface
body material consisting of seamlessly
sintered PE
corners good cleaning performance
filter area relatively large area
of 0,25 to 7,6 m²
reinforcement to stabilise and locate
filter element
compact rigid structure to cope with abrasive and
extremely fine dusts
Components of HSL – filter element
high degree of
separation
extremely long
service life approved and certified stiff body
© 2009
9 Pharmaceutical Industry
Filter element
approved and certified separation efficiency for use for dust class M (DIN EN 60335-2-69)
approved and certified separation efficiency as HEPA filter rated class R (DIN 24 184) comparable to HEPA H11 (EN 1822)
approved and certified antistatic version surface resistance < 109 Ohm and leakage resistance < 108 Ohm (BGR 132 “Avoiding of ignition dangers due to electrostatic charging”)
approved and certified non-chargeable design (DIN EN 13463 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)
© 2009
10 Pharmaceutical Industry
Prüfmittel Staubklasse Verwendungszweck max.
Durchlassgrad
L Stäube mit MAK-Werte > 1 mg/m³ 1,0 % Quarz-staub 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 %
Dust classes according EN 60335-2-69 amendment AA
„… … 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“ …“
Filter element Categorie H
© 2009
11 Pharmaceutical Industry
Filter units with second filter stage
HEPA-
Filter
mounted on
outlet
HEPA-
Filter
integrated
mounted aside
HEPA-
Filter
© 2009
12 Pharmaceutical Industry
Process technique
- spraying period
(this means no Jet-Puls-Cleaning of the dusts during the spraying period)
separate
with water based or organic solvents
„Separating the process“
At agglomeration, drying and coating processes
- Agglomerating-, drying- and heating period
from
The protective measurement „Avoiding effective ignition
sources proves to be sufficient for most applications
© 2009
13 Pharmaceutical Industry
according VDI 3673
„Pressure relief of dust
explosions“
Handling of explosive dusts
© 2009
14 Pharmaceutical Industry
Explosion suppression
according VDI 2263 Part 4
„Suppression of dust explosions“
- Installation in working rooms
- for toxic dusts
© 2009
16 Pharmaceutical Industry
Herding® HSL-PharmEx Filter
expansion space
(clean gas room)
control panel
secondary filter with
HEPA-filter H13
clean gas outlet
cleaning device
interface for different
dust collecting
systems (optional)
raw gas room with
HSL-elements
foot height according to
dust disposal system
raw gas inlet (back)
Separation organic dusts
KST-Value up to 300 bar m/s
Max. explosion pressure 10 bar
Pressure in Filter unit < 0.7 bar
© 2009
17 Pharmaceutical Industry
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
Alternative to 2-stage filter unit
No zone barrier Dust zone barrier
High separation efficiency no need for
change of downstream installed
HEPA-filter
© 2009
18 Pharmaceutical Industry
Adhesive dusts
Use of Pre-coating devices
for very sticky dusts after fluid bed
coaters
for example for Acryl-resin
(EUDRAGIT®)
© 2009
20 Pharmaceutical Industry
De-dusting from strongly adhesive products
Silo for precoat material Dust disposal drum
Precoater for building
filter auxiliary layer
© 2009
21 Pharmaceutical Industry
„First Rinse“
Raw gas compartment
after washing
Dust-loaded raw gas compartment in the area of the
spray lances
Dust-loaded, raw gas compartment
contaminated
Spray lances after
washing
View of the hopper
from above
© 2009
23 Pharmaceutical Industry
Low-contamination dust disposal
mechanical pneumatically
Pneumatical
dust discharge … … to the external
dust disposal
pneumatical dust discharge
continuous lining
© 2009
24 Pharmaceutical Industry
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
© 2009
25 Pharmaceutical Industry
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® Sinter-
plate filter elements
4 = Liner
5 = Welding frame
6 = Fibre-Drum
7 = scale for monitoring
of filling level
© 2009
26 Pharmaceutical Industry
Central dust disposal
Pneumatic dust discharge out of
different filter plants
Details from Continuous-Liner-
System
© 2009
27 Pharmaceutical Industry
Welding of plastic bag for dust disposal
welding systematic
Separation weld
6
6
3
3
600
© 2009
28 Pharmaceutical Industry
Central de-dusting system modernisation
Filter system with low pressure
level dedusting and vacuuming
© 2009
29 Pharmaceutical Industry
Central and no contamination dust disposal
Central dust disposal plant Dust discharge in Continuous-
Liner-System
© 2009
30 Pharmaceutical Industry
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