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Cleaning Recommendation For Flow Sciences Top Mount Enclosures
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Cleaning Recommendation For Flow Sciences Top Mount Enclosures

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Cleaning Recommendation for Flow Sciences Top Mount Safety Enclosure using Berkshire wipes

Cleaning Recommendation for Flow Sciences Top Mount Safety Enclosure using Berkshire wipes

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  • 1. Cleaning Protocol for Top Mount Enclosure
  • 2. Prior to cleaning, gown according to written protocols for the area and the material being handled:  Latex Gloves, Dust Mask, Buoffant Cap, Safety Glasses, and Tyvek Suit.
  • 3. Option 1: Pre-saturated wipes saturated with 70/30 IPA/DIW solution. Prior to cleaning, we'll review proper technique.
  • 4. Option 2: Dry wipes.  These should be wetted with a 70/30 IPA/DIW solution after folding. Prior to cleaning, we'll review proper technique.
  • 5. Place the wiper flat on the surface. Take the two farthest ends from you and bring them towards you, folding the wiper in half.
  • 6. Fold the wiper in half again, creating four cleaning faces: two outside and two inside.
  • 7. Work from the cleanest areas to the dirtiest areas in long straight strokes. Each face of the wiper will be used for one stroke. Turn wiper over and make a second stroke.
  • 8. Refold the wiper as shown in step 2 to enclose the two contaminated faces and expose the two clean faces. Repeat step 3 using the two clean faces.
  • 9. Wiper may be completely unfolded, reversed, and refolded beginning again at step 1 to enclose the four contaminated faces and expose the four remaining clean faces.
  • 10. General Wiping Technique Summary
    • Quarter fold the wiper to produce several clean surface areas.
    • When wiping hold the wiper so that the folded edge is pointed toward the area to be wiped.
    • Use either a pre-saturated wiper or a dry wiper pre-saturated with 70/30 IPA/DIW solution.
    • Wipe in a single direction overlapping the wiping strokes by 10% on each successive stroke to eliminate re-contamination of the clean adjacent surface.
    • For each new stroke, change to a clean wiper surface area.
    • Always wipe from the cleanest area to the least clean area.
    • Systematically clean from top to bottom and front to back as surfaces are wiped to avoid re-contamination of cleaned areas.
    • Dispose of wipers according to the facility waste protocols.
  • 11. Wipe down all cleaning materials and gloved hands with wipers saturated with 70/30 IPA/DIW prior to placing them in the unit.
  • 12. Start cleaning with one single stroke across front airfoil on door. Re-orient wiper to clean side for next area to be cleaned.
  • 13. Clean interior of front door. Start at highest point on door and work towards the bottom. Wipe from left to right, overlapping 10% on each successive wiping stroke.
  • 14. Wipe the area above door on interior from one side to the other.
  • 15. Wipe the base air foil.
  • 16. Once cleaning begins inside the enclosure: Start with cleaning removable top panel.  Work from left to right, wiping back to front.
  • 17. Remove upper panel – slight lift at the rear of panel and slide back. Drop front edge just below front lip and slide forward to clear rear panel. Once clear, lower back panel at an angle and bring to base. Rest front edge of panel on front, side airfoils. ** During the removal process, be careful to not raise panel too high as blower can create suction that can pull panel upwards to obstruct filter.
  • 18. Wipe leading edge from left to right. Then on top side, wipe from front to back. Stand panel up and wipe reverse side from top to bottom. Remove cleaned panel from enclosure.
  • 19. Wipe down front of rear baffle (Use EasyClean ™ 360 Isolator Cleaning Tool) to reach beyond arms length. The cleaning tool cover should be changed when visibly soiled and between surface cleanings.
  • 20. Remove rear baffle and rest on front, side airfoils. Start on one side and wipe from front to back with 10% overlap with each pass. Remove clean baffle from enclosure.
  • 21. Clean all upper surfaces (do not disturb HEPA filter).
  • 22. Next clean back panel either by wiping from top to bottom with wiper or by using EasyClean ™ 360 Isolator Cleaning Tool. The cleaning tool cover should be changed when visibly soiled and between surface cleanings.
  • 23. Use smooth strokes top to bottom applying light pressure.
  • 24. Clean both the right and left side of the enclosure. Start at back and move forward, wiping from top to bottom. Be sure to wipe down any hooks or screwheads. Also wipe down side airfoils.
  • 25. Clean the rear baffle supports. For this purpose a cleanroom swab may also be used.
  • 26. Wipe sides from back to front.
  • 27. Use smooth strokes top to bottom.
  • 28. Wipe around the access panel.
  • 29. Wipe front air foils top to bottom.
  • 30. Wipe down the base of the enclosure wiping from back to front.
  • 31. Last step, re-wipe front airfoil.
  • 32. Repeat the cleaning process and re-install the rear baffle and upper panel. The recommended cleaning frequency is at the start of each shift and between compound or material changes.
  • 33. Recommended Berkshire Cleaning Product Options
    • Pre-Saturated Non-Woven Wipers
      • SPX670R.001.12
      • SPX550.001.24
      • SPXC1000.24
    • Dry Non-Woven Wipers
      • DR670.0909.20
      • VCL.0909.20
    • Cleaning Tool
      • EC360.ICT.1
    • Tool Covers
      • EC360.EC.6
    • Swab
      • LT000125.10
    • Pre-Saturated Polyester Wipers
      • SPXHAR.001.12F
    • Dry Polyester Wipers
      • MSVP.0909.8
    • Cleaning Tool
      • EC360.ICT.1
    • Tool Covers
      • EC360.EC.6
    • Swab
      • LT000125.10
    Economical - “Low Linting” Best - “Non-Shedding” For more information on Berkshire’s contamination control products call today at 1.800.242.7000 or e-mail us at csr@berkshire.com.
  • 34. Sterile & USP <797> Application Notes
    • For sterile or USP <797> applications a more rigorous cleaning routine is required and the use of “non-shedding” polyester wipers is recommended. For sterile or aseptic applications it is also recommended that any cleaning product used is sterile.
  • 35. USP <797> Cleaning Requirement Critical Site Minimum Frequency Monthly Storage shelves Monthly Ceilings Monthly Walls Daily Floors Daily Counters and work surfaces
    • At the beginning of each shift.
    • Before each batch.
    • Not longer than 30 minutes after the previous surface disinfection ( during ongoing compounding activities ).
    • After spills.
    • When surface contamination is known or suspected.
    ISO Class 5 primary engineering controls
  • 36. Sterile & USP <797> Application Notes
    • For sterile or USP <797> cleaning, a 4 step process is typical:
    • Clean using an approved detergent and dry wipers to remove any residues from the previous run.
    • Remove residual detergent by cleaning with pre-wetted 70/30 sterile wipers or sterile dry wipers wetted with sterile DIW or sterile 70/30 IPA.
    • Disinfect the surfaces with pre-wetted 70/30 IPA sterile wipers, another disinfecting agent or a liquid sterilant utilizing sterile dry wipers.
    • Remove residual disinfectant or sterilant with pre-wetted 70/30 IPA sterile wipers or sterile dry wipers wetted with sterile DIW or sterile 70/30 IPA.
  • 37. Recommended Berkshire Cleaning Product Options – Sterile
    • Sterile Pre-Saturated Non-Woven Wipers
      • SSP670.001.24
    • Sterile Dry Non-Woven Wipers
      • GW67.ST.25
    • Cleaning Tool
      • EC360.ICT.1
    • Tool Covers
      • EC360.ST.20
    • Sterile Pre-Saturated Polyester Wipers
      • SSPHA.001.12
    • Sterile Dry Polyester Wipers
      • GW120.ST.15
      • GWHA.ST.10
    • Cleaning Tool
      • EC360.ICT.1
    • Tool Covers
      • EC360.ST.20
    Economical - “Low Linting” Best - “Non-Shedding” For more information on Berkshire’s contamination control products call today at 1.800.242.7000 or e-mail us at csr@berkshire.com.