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Presentation to. Occupational and Patient Protection from Exposure. Agenda. Powder Explosion The Specialists View, fear is the key A simpler approach West and TWA 800 as case studies The FAA solution to the same problem the Pharmaceutical industry faces Examples

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  1. Presentation to Occupational and Patient Protection from Exposure 2008 PharmaConsult Us Inc.

  2. Agenda • Powder Explosion • The Specialists View, fear is the key • A simpler approach • West and TWA 800 as case studies • The FAA solution to the same problem the Pharmaceutical industry faces • Examples • Flexible versus Rigid the never ending debate • Disposable • Reusable

  3. Dust explosion kills six, destroys West Pharmaceutical Services plant, Kinston, NC, Jan. 29, 2003.

  4. Basics For a fire or an explosion to occur, three conditions must be met: A combustible substance must be present An oxidizing agent must be present; usually this is atmospheric oxygen A source of ignition of sufficient energy must be active. If and only if these three conditions prevail at the same time, fire or explosion are possible. Eliminate one of the above and explosion cannot occur

  5. A Dust Explosion Oxygen Confinement Ignition Combustibility Dispersion

  6. Explosion Pentagon • Oxygen to support Combustion normally atmospheric 2% O2 for Solvent 5% for Dust • Ignition could be electrostatic discharge, Electrical Equipment should be rated if removal of ignition is the chosen route • Dispersion Requires energy to produce cloud, (could be initiating explosion) (West) • Confinement to achieve concentration could use ventilation to achieve dilution below concentration • Combustible has to be combustible but low mass high area dusts are combustible (Aluminum)

  7. Make it easy; Loose the Oxygen . TWA 800 The crash killed all 230 people on board the flight from New York to Paris. NTSB officials hope that the hearings may help clarify the circumstances surrounding one of the most mysterious air disasters in US history

  8. Explosion Pentagon TWA 800 • Oxygen to support Combustion normally atmospheric 2% O2 for Solvent 5% for Dust • Ignition Electrical, chafed wiring • Dispersion Requires energy sat in hot sun for 4 hours. • Confinement Closed fuel tank • Combustible aviation fuel heated by sun

  9. Solution Nitrogen by Filtration

  10. Examples of Inerted Isolators 2008 PharmaConsult Us Inc.

  11. Key Features • Low nitrogen flow rate 1-2 ACH • O2 Sensor Isolates electrical supply when out of range and alarms • Room is not involved not rated • O2 Sensor must be protected from environmental O2 use closed loop peristaltic or venturi vacuum. • Inertion is very dry

  12. Small scale API in an Isolator

  13. Results

  14. Results Start/finish

  15. Results Start/finish

  16. Results Start/finish

  17. Oven Isolator Test result no sample with detected Naproxen Sodium

  18. This isolator has two baffle plates at either end and a top 12” TC for Vacuum transfer, it also has planks for general purpose uses and for staging. This isolator is an adaptable workhorse that has even been adapted to control slave isolators attached to it General Purpose Isolator

  19. Mill

  20. Filtration and Vacuum Tray Drying with 500 gallon Vessels in a Safelab unit

  21. Formulation

  22. Equipment Integration Development Scale in a Box

  23. Bench Top Chemistry Dilution

  24. Issues Charging Layering Sampling Heel retention Wet Milling Cleaning Ergonomics 200 L High Shear Granulator

  25. The original concept was a sketch drawing showing the GPCG, mill and granulator An ergonomic model was built to evaluate the issues, and the process was run. The cage was made from water pipe and the GPCG was modified so that the bowl slid out without using the cart. Concept to reality 6 weeks The Flexible Solution GPCG 5

  26. The bag project took 6 weeks and showed that in normal operation the bag provided reasonable protection, The problem came in disassembling the bag and cleaning the equipment, because the bag had limited transfer capability and because cleaning a flexible film is difficult and finally because of the size and weight of the objects to be cleaned the results were not a good as expected and so the decision to provide a fully engineered rigid solution was made Personal Samplers Flexible Film SolutionActual Performance Using API

  27. “Hot” Replacement of the Bagging Tube

  28. Bagging Out

  29. Bagging In

  30. Uses readily available tools, Uses readily available lay flat tube, the basic material of PE Bags Effective and cheap Crimp and Cut

  31. RTP port and bag Can be a bagging ring to allow canister or bag transfer Tool shown is used to open a Beta port without an Alpha port, can only be used with a clean bag or in an emergency with the correct precautions Rapid Transfer Port/ Bag

  32. FIBC Transfer

  33. FIBC Transfer Issues • Cost of Bag • Port recovery, or greater cost with disposable port • Prevention of powder on seals • Can be Split Butterfly valve, but the cost is higher for the passive and recovery is essential, there are no disposable SBV’s currently • Consider Hycoflex

  34. Canopy about $ 1,000 but would be cheaper in volume Airflow issues due to disposable filters User acceptance issues Performance was below 0.1 mcg/m3/duration Laboratory Disposable Canopy Isolator

  35. Access to V Blender • Development Batch • 5 cu ft PK blender • Mobile platform and disposable bag isolator • Tubular removable frame • Lay flat tube connection to manways • $ 7,000 and 4 Weeks • Stellar performance below limit of detection

  36. Sampling left and right Front and back Top, Middle Bottom 3 Sample sets 30 samples 3 Batches Mock up adapter and bagging ring on V bleneder, added to an existig 5 cu ft PK Blender 5 cu ft V blender

  37. Tablet Press, De-Dust and Test

  38. Press in a Bag • Occupational exposure data showed that the active bonded to the excipient so successfully that an API with an OEL of 0.07mcg/m3/10hrs. Resulted in exposures without the bag below the required limit • The bag was dispensed with.

  39. Development OSD in a Flexible Film

  40. Laboratory Isolators

  41. Issues with Flexible Film Solution • The air flow in the isolator was low due to the type of filter and the absence of an air handling system… It was tied to the dust collector • Was prone to the high physical demands caused by the handling requirement • Handling was an issue even with a slide for the FBD Bowl • Accidental over pressure on the bearing caused explosive discharge from the granulator • The IH results were good in operation but during cleaning and removal but the risks were considered too high

  42. Baffle Plate Equipment Multi Use Isolators

  43. Occupational v Product ExposureRisks and Opportunities • Breakdown the EH&S/ Quality and Compliance Silos • Great opportunity for CIH to leverage into a position that is core Quality • Differences between Occupational and Product Exposure data • Multi product high hazard facilities will have to conduct risk assessment • Current study using surrogate and placebo batches OSD and Parenteral formats and typical IH sampling at the same time to address the perception of cross contamination

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