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Controlled Environments and Cleanroom

Fisher Scientific partners with companies across industrial markets such as biopharma and personal care to deliver custom-tailored cleanroom solutions.

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Cleanroom Protocols

Restricted Activities

  • Shouting
  • Running or fast movements
  • Writing on walls, gloves, equipment or garments
  • Touching, rubbing, or scratching the hair, skin, eyes while in the cleanroom
  • Removing any piece of cleanroom apparel inside the cleanroom
  • Eating, chewing gum, cough drops, breath mints, etc.
  • Use of tobacco in any form
  • Wearing contaminated, soiled or torn cleanroom garments
  • Use of duct tape
  • Excessive talking
  • Re-using shoe covers or booties, face mask, hair covers or gloves
  • Wearing of shorts, midriff tops, tank tops or hats
  • Wearing dangling jewelry
  • Talking under laminar hood
  • Removing articles from underneath cleanroom garment
  • Sanding, drilling, sawing, filing, and welding

Bringing Items Into a Controlled Environment

  • Any item brought into the cleanroom must be thoroughly wiped down with an approved cleanroom wipe and solution such as 9% alcohol (IPA) and DI water
  • Tool boxes should not be brought in unless they have been approved and completely wiped, including their contents
  • All supplies must enter the cleanroom through the Equipment or Material Pass-through area
  • Parts being brought in for installation must be removed from their package if wood, cardboard or paper of any kind
  • Usually, plastic bags can be employed for carrying numerous items necessary for your job
  • Wood materials are unacceptable in the cleanroom

Minimum Gowning Requirements

  ISO 3 (FED 209E Class 1) ISO 4 (FED 209E Class 10) ISO 5 (FED 209E Class 100) ISO 6 (FED 209E Class 1,000) ISO 7 (FED 209E Class 10,000) ISO 7 (FED 209E Class 100,000)
Hair Cover
Hood      
Beard Cover
Face Mask      
Frock        
Coverall    
Shoe Covers
Boots      
Gloves  

U.S. FED STD 209E Cleanroom Standards

particle/ft3
Class 0.1 µm 0.2 µm 0.3 µm 0.5 µm 1 µm 5 µm
1 35 7 3 1    
10 350 75 30 10 1  
100 3,500 750 300 100 10 1
1,000       1,000 100 10
10,000       10,000 1,000 100
100,000       100,000 10,000 1,000

ISO 14644-1 Cleanroom Standards

particle/m3
Class 0.1 µm 0.2 µm 0.3 µm 0.5 µm 1 µm 5 µm
ISO 1 10 2        
ISO 2 100 24 10 4    
ISO 3 1,000 237 102 35 8  
ISO 4 10,000 2,370 1,020 352 83  
ISO 5 100,000 23,700 10,200 3,520 832 29
ISO 6 1,000,000 237,000 102,000 35,200 8,320 293
ISO 7       352,000 83,200 2,930
ISO 8       3,520,000 832,000 29,300
ISO 9       35,200,000 8,320,000 293,000

Cleanroom Class Comparison

ISO 14644-1 FED STD 209E
ISO 3 1
ISO 4 10
ISO 5 100
ISO 6 1,000
ISO 7 10,000
ISO 8 100,000
Irradiated Product Validated Sterile Product
Not recognized by the FDA or Pharmaceutical companies as an accepted validation method ANSI/AAMI/ISO-Global Standards for the validation of sterile products
Post-Sterilization validation (USP sterility test) Pre-sterilization validation
Quarantine period (~ 2 weeks) No quarantine period
Every lot tested Quarterly audits including bio burden monitoring, exposure of 100 units 10-2 dose, sterility testing on 100 units, packaging burst test
Higher dose of radiation delivered to the product than might be necessary to render sterility (typically 25 KGy minute dose) Dose based on bioburden and desire SAL
Predicted SAL = 10-1.3 Predicted SAL = 10-6
Industry Reference

Gowning

Proper Gowning Procedures

  • The gowning area must be kept clean and proper procedures must be adhered to at all times
  • Use Tacky Mats and/or shoe cleaner
  • Remove watches, rings, all jewelry
  • Dress from the top down in the following order:
    • Pre-donning booties
    • Hairnet
    • Beard cover/facemask
    • First pair of gloves
    • Hood
    • Safety glasses
    • Coveralls (first pair of gloves under sleeves)
  • For sterile environments: step over gowning bench to controlled area as overboots are donned:
    • Overboots
    • Second pair of gloves (to be worn over the sleeves of the coverall)
  • For sterile environments: decontaminate gloves w/IPA or suitable disinfectant prior to entering aseptic room

Frequency of Change

  • This frequency is for minimum recommended usage only
  • Masks and gloves should be changed at least once per work session
  • Gloves should be disinfected prior to entering into an aseptic area, regularly disinfected during operations and before contact with an aseptically gowned person
  • The specific protocol for the facility must be followed:
ISO 4 (FED 209E Class 10) Per entry
ISO 5 (FED 209E Class 100) Daily
ISO 6 (FED 209E Class 1,000) Daily
ISO 7 (FED 209E Class 10,000) Daily
ISO 8 (FED 209E Class 100,000) Every other day
Sterile area Per entry
Specialists

Randy Monger
CE Sales Manager
+1 804-301-4760

Kevin Ketchem
Production Sales & Implementation Manager
+1 512-589-9275

Mark Vogel
+1 602-432-6345

Russ Laibl
+1 661-857-5382

Deborah Haring
+1 314-795-3618

Bruce Weiss
Global Industry Director/CE Business Development
+1 214-924-4251

Chris Miller
+1 613-240-3122

Linda Wallin
+1 732-610-3303

Chris Hayduk
+1 919-332-2580

Jaqueline Pelliccia
+1 787-431-0427


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