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


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


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


Containment-Systematic

© 2009


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


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


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


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


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


Filter units with second filter stage

HEPA-

Filter

mounted on

outlet

HEPA-

Filter

integrated

mounted aside

HEPA-

Filter

© 2009


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


according VDI 3673

„Pressure relief of dust

explosions“

Handling of explosive dusts

© 2009


Explosion suppression

according VDI 2263 Part 4

„Suppression of dust explosions“

- Installation in working rooms

- for toxic dusts

© 2009


PharmEx Filter

© 2009


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


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


Adhesive dusts

Use of Pre-coating devices

for very sticky dusts after fluid bed

coaters

for example for Acryl-resin

(EUDRAGIT®)

© 2009


Adhesive dusts

Complete filter system

© 2009


De-dusting from strongly adhesive products

Silo for precoat material Dust disposal drum

Precoater for building

filter auxiliary layer

© 2009


„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


SafeChange for the exchange of filter elements

© 2009


Low-contamination dust disposal

mechanical pneumatically

Pneumatical

dust discharge … … to the external

dust disposal

pneumatical dust discharge

continuous lining

© 2009


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


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


Central dust disposal

Pneumatic dust discharge out of

different filter plants

Details from Continuous-Liner-

System

© 2009


Welding of plastic bag for dust disposal

welding systematic

Separation weld

6

6

3

3

600

© 2009


Central de-dusting system modernisation

Filter system with low pressure

level dedusting and vacuuming

© 2009


Central and no contamination dust disposal

Central dust disposal plant Dust discharge in Continuous-

Liner-System

© 2009


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

© 2009 Pharmaceutical Industry

Thank you for your attention

Herding GmbH Filtertechnik

Amberg, Germany www.herding.de

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