1.
Considerations for reducing
risk and increasing
containment performance
Michael G. Avraam
Global Product Manager - Containment
ChargePoint Technology
Tuesday 24th June

2.
REDUCING RISK
HAZARDOUS PHARMACEUTICAL SUBSTANCES
• Personal exposure
• Environmental contamination
• Product cross contamination

3.
DEFINITION OF HPAPI
What is a…
High potency Active Pharmaceutical Ingredient
(HPAPI) ?

4.
CONTAINMENT PHILOSOPHY
Relatively
harmful, but
low risk
Use of good
work 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 risk
suspected
carcinogenic
Improved PPE
and/or
containment
process
Irreversible effects
DNA, mutagenicity
and chromosomal
damage
Higher level
containment
systems. Minimal
human intervention

5.
REDUCING THE RISK OF EXPOSURE
“There is no quick and easy
solution to the problem”

6.
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

7.
DETAILED CONSIDERATIONS
Having established risk potential, need to
Identify other process considerations

8.
DETAILED CONSIDERATIONS
• Product toxicity (OEL)

9.
DETAILED CONSIDERATIONS
• Flammability

10.
DETAILED CONSIDERATIONS
• Material Type

11.
DETAILED CONSIDERATIONS
• Process

12.
DETAILED CONSIDERATIONS
• Potency

13.
DETAILED CONSIDERATIONS
• Quantity - What is the total
quantity being handled

14.
DETAILED CONSIDERATIONS
• Task & Duration - What is the process task and
the actual activity taking place

15.
DETAILED CONSIDERATIONS
• Intervention - The level of operator
involvement and risk to operator

16.
DETAILED CONSIDERATIONS
• Operator – Fully trained and adherence to
Standard Operating Procedures – S.O.P’s

17.
CONTAINMENT SOLUTION SELECTION
• Level of risk
• Detailed considerations
• Containment solution analysis and selection

18.
WHAT TYPE OF CONTAINMENT
SOLUTION?
• Cleanrooms
• PPE (Personal Protection Equipment)
• LEV (Local Exhaust Ventilation)

19.
WHAT TYPE OF CONTAINMENT
SOLUTION?
• Flexible containment

20.
WHAT TYPE OF CONTAINMENT
SOLUTION?
• Downflow Booths

21.
WHAT TYPE OF CONTAINMENT
SOLUTION?
• Flexible Isolators

22.
WHAT TYPE OF CONTAINMENT
SOLUTION?
• Rigid Isolators

23.
WHAT TYPE OF CONTAINMENT
SOLUTION?
• Powder Transfer Systems

24.
WHAT TYPE OF CONTAINMENT
SOLUTION?
• Split butterfly valves

25.
WHAT TYPE OF CONTAINMENT
SOLUTION?
Focusing on Split Butterfly Valve Technology

26.
UTILISING A SPLIT BUTTERFLY VALVE
AS THE CONTAINMENT SOLUTION
General Composition
• Active – Normally fitted to process
• Passive – Normally fitted to product IBC or Bag

27.
SPLIT VALVE OPERATION PRINCIPLE
Active &
Passive Disc
OPEN / CLOSE
Active and Passive
UNLOCK
and Passive
UNDOCK
Passive
& Active
DOCKING
Active and
Passive
LOCK

28.
TYPICAL APPLICATIONS FOR SPLIT
BUTTERFLY VALVES
• Dispensing
• Reactor / Vessel Charging
• Nutsche Filter dryer discharge
• HSM / Granulator charging & discharging
• Mill / Sieve charging & discharging
• Compression machine charging
• Encapsulation machine charging

29.
INCREASING CONTAINMENT
PERFORMANCE
General approach and options towards improving
containment performance with split butterfly valves

30.
INCREASING CONTAINMENT
PERFORMANCE
• S.O.P’s
Enhanced S.O.P procedures

31.
INCREASING CONTAINMENT
PERFORMANCE
• Contamination removal by local extraction

32.
INCREASING CONTAINMENT
PERFORMANCE
• Contamination removal by integral extraction

33.
INCREASING CONTAINMENT
PERFORMANCE
• Contamination and residue rinsing
Rinsing Solution
Introduction
Rinsing Solution
Recovery

34.
INCREASING CONTAINMENT
PERFORMANCE
• Secondary barrier

35.
INCREASING CONTAINMENT
PERFORMANCE
• Provision of accessories by integration
whilst maintaining containment

36.
INCREASING CONTAINMENT
PERFORMANCE
• Preventative maintenance

37.
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

38.
OVERVIEW
SUCCESS

39.
Follow us
Michael G. Avraam
mike.avraam@thechargepoint.com
Thank you
Any Questions?