Considerations for reducing risk and increasing containment performance

Considerations for reducing risk and increasing containment performance

Michael G. AvraamGlobal Product Manager - ContainmentChargePoint TechnologyTuesday 24th June

REDUCING RISK

HAZARDOUS PHARMACEUTICAL SUBSTANCES

• Personal exposure• Environmental contamination• Product cross contamination

DEFINITION OF HPAPI

What is a…High potency Active Pharmaceutical Ingredient (HPAPI) ?

CONTAINMENT PHILOSOPHY

Relatively harmful, but

low risk

Use of goodwork practices

and general ventilation

Moderate risk skin, eye and

respiratory tract irritation

Use of Local Exhaust and Ventilation (LEV)

and appropriate Personal Protection

Equipment (PPE)

High risksuspected

carcinogenic

Improved PPE and/or

containment process

Irreversible effects DNA, mutagenicity and chromosomal

damage

Higher level containment

systems. Minimal human intervention

REDUCING THE RISK OF EXPOSURE

“There is no quick and easysolution to the problem”

RECOMMENDATIONS FOR PRIMARY LEVEL RISK REDUCTION

Recommendations to reduce risk

• Contain airborne risk at source• Avoid reliance on Standard Operating Procedures (S.O.P.’s)• Containment system selection• Targeting level of design performance• Introducing a secondary barrier• Reducing reliance on PPE• Other considerations

DETAILED CONSIDERATIONS

Having established risk potential, need toIdentify other process considerations


• Product toxicity (OEL)


• Flammability


• Material Type


• Process


• Potency


• Quantity - What is the total quantity being handled


• Task & Duration - What is the process task and the actual activity taking place


• Intervention - The level of operator involvement and risk to operator


• Operator – Fully trained and adherence to Standard Operating Procedures – S.O.P’s

CONTAINMENT SOLUTION SELECTION

• Level of risk• Detailed considerations• Containment solution analysis and selection

WHAT TYPE OF CONTAINMENT SOLUTION?

• Cleanrooms • PPE (Personal Protection Equipment)• LEV (Local Exhaust Ventilation)


• Flexible containment


• Downflow Booths


• Flexible Isolators


• Rigid Isolators


• Powder Transfer Systems


• Split butterfly valves


Focusing on Split Butterfly Valve Technology

UTILISING A SPLIT BUTTERFLY VALVEAS THE CONTAINMENT SOLUTION

General Composition

• Active – Normally fitted to process• Passive – Normally fitted to product IBC or Bag

SPLIT VALVE OPERATION PRINCIPLE

Active &

Passive Disc

OPEN / CLOSE

Active and Passive

UNLOCK

and Passive

UNDOCK

Passive

& Active

DOCKING

Active and

Passive

LOCK

TYPICAL APPLICATIONS FOR SPLITBUTTERFLY VALVES

• Dispensing• Reactor / Vessel Charging• Nutsche Filter dryer discharge• HSM / Granulator charging & discharging• Mill / Sieve charging & discharging• Compression machine charging• Encapsulation machine charging

INCREASING CONTAINMENT PERFORMANCE

General approach and options towards improvingcontainment performance with split butterfly valves


• S.O.P’s Enhanced S.O.P procedures


• Contamination removal by local extraction


• Contamination removal by integral extraction


• Contamination and residue rinsing

Rinsing SolutionIntroductionRinsing Solution

Recovery


• Secondary barrier


• Provision of accessories by integration whilst maintaining containment


• Preventative maintenance

OVERVIEW

• Understanding the risk• Identify the process• Target the containment performance• Establish the appropriate solution• Minimise reliance on PPE• Familiarise the users• Integration and correct installation• Rigorous training and monitoring• Maintenance

OVERVIEW

SUCCESS

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Michael G. [email protected]

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Considerations for reducing risk and increasing containment performance

Engineering

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