dry cleaning high potent solid drugs - kierunek … · dry cleaning oel and oeb basics ... why do...

Overview Themes 1 © 2005 Höfliger, Forum 2005

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Cleaning of MC

DRY CLEANING

OEL and OEB

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Safe Handling of

High Potent Solid Drugs

Pharmaceutical Conference Poland


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General Requirements

What are high potent drugs ?

and

Why do high potent drugs require special handling?The exposure of the product (API) over a certain time will be harmful for the operator

The emission of the drug substance (API) to the ope rator is linked to the MAK value. To prevent negative influences to t he human body the operator protection is mandatory.

MAK: Maximum Allowed Concentration (largest amount of health damaging gases and fumes, volatile or floating materials that can be born with out health damage during 8 working hours.

Example for MAK:

Paracetamol: 10mg/m³

Foradil: 1µgr/m³

But high potent drugs are not toxic!!


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Definition for the Exposure to the operator (Emissi on)


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Example of OEB


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Available solutions for operator protection

Operator gowning with Machine with containment

protective garments


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Limits of Containment

A containment enclosure prevents the operator from being exposed to the API during regular production.

but

When is the operator able to open the machine conta inment?

What about the exposure limits in the machine?

- Limits for the air inside the production room?

- Limits for the machine surface?

=> Methods e.g. WIP to reduce the exposure inside t he machineare needed!!


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Comparison Machine with Containment and with WIP

Capsule Filling machine, 100.000c/h equipped with:

1x basic machine

1x dosing station

1x format part set

1x containment

1x line equipment (deduster, transfer units, checking system, vacuum cleaning and air handling system)

Costs: 1,2 Mio Euro

Above machine in WIP execution:

Costs: 4,2 Mio Euro


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WIP is the standard answer in the industry for clea ning!

BUT: Is washing in place the best solution?

How clean is WIP?

What are the criteria's to make a judgment of what is clean?

Is the WIP Machine that clean, to open the containm ent?

Is the cleanness of the machine direct measured?

How clean is the air inside the machine?

How clean are the machine surfaces in the machine?

What is the maximum allowed concentration of API?(OEL is an average concentration)


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WIP is the current used method to reduce the exposu re

Current disadvantages of the WIP cleaning process!!• No possibility to open the containment for manual trouble shooting

• Remaining bacteria in the piping due to washing solvent.

• Problems with crystallization of the API which leads to leakage of the seals

• Cost to recycle the waste water and cost for lost API while cleaning

• Due to the capillary force of the washing solution, the API remains in small gaps of the machine which are bolted together and are not sealed

• Adhesion force of the API is 10 times higher when exposed to water

• Water proofing measures and effectiveness will diminish over time

• Weight of handling parts are heavy due to the use of stainless steel

• Indirect measurement of waste water to determine the cleanness

• Machine surface is not completely clean and requires manual cleaning

• Total Cleaning time of the machine (washing and drying)

• Price of such a machine=> Is WIP the future ?


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Alternative to WIP?

DRY CLEANING Concept:

Target:

To reduce the number of particles in the air as wel l as at the machine surfaces before opening the containment to protect the operator and the GMP room from exposure to the API

Allow the opening of the machine containment in the production without loss of time and API

Limits for airborne particles: 1µg/cm³

Limit for machine surface: 1 µg/cm²

Target costs: 40%less as the WIP Machine!!


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Alternative to WIP?

HH Strategy/ Content of the DRY CLEANING Concept:

ModuC MS:

1. Determine the places of most powder spillage in the machine.

2. Reduce the powder loss in the machine.

3. Create an area for simple handling of parts and failures

4. Dry cleaning by compressed air and vacuum suctio n

5. Final cleaning with dry cleaning solvent.

6. New methods for the determination of the limits for airborne particle and machine surfaces.


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Detailed machine concept, ModuC MS

For more information about the DRY CLEANING Concept

please contact us at our booth (Trade & Consult)


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Detailed machine concept

Free access to handling area for manual trouble shooting


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Air handling for operator protection

Compensation box for return air to

ensure good underpressure control in the containment

The air handling unit is supplied with

return air and with air out of the

cleanroom

Air handling unit for temperature

and humidity control

Technical area

Production room


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Decontamination Concept as alternative for WIP

Advantage of ModuC “Dry Cleaning Concept”:

Operator protection during production and decontami nation before manual final cleaning

Containment in defined under pressure for protectio n of the operator against high potent or toxic emissions

Avoiding the use of cleaning water to reduce waste and disposal cost

Avoiding powder spillage in the production area due to housing of the powder trolley and addition cleaning of the lower s egments

Opening the machine for trouble shooting, access to all relevant parts without gloves and without loss of API

Standard machine sealing is sufficient to prevent l eakage

Trolley machine concept can be used for more flexib ility

Time for decontamination process is only 30 minutes


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What is Occupational Exposure Limit (OEL)?


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Definition for the Exposure to the operator (Emissi on)

How useful are these limits OEL and OEB?

Does it tell me how good the machine protects the o perator?

What are the maximum allowed limits?

Are there any difference in the limit during produc tion or at the end of the production?

When opening the machine, how clean is the air insi de the machine room and what about the machine surfaces?

dry cleaning high potent solid drugs - kierunek … · dry cleaning oel and oeb basics ... why do...

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