Maximum Patient Protection and Sterility
Ergonomic Enhancements
Cabinet Construction
Microprocessor Control
Isolator Airflow
Validated Performance
Engineering Details 4' Model
Engineering Details 6' Model
Technical Specifications
 
Safe Use
USP 797
 

North America
Esco Technologies, Inc.
2940 Turnpike Drive,
Units 15-16,
Hatboro, PA 19040, USA

Toll-Free: 1-877-479-3726
Phone: 215-441-9661
Fax: 215-441-9660
usa@escoglobal.com



Asia-Pacific
Esco Micro Pte Ltd
21 Changi South Street 1
Singapore 486777

Tel: +65 6542 0833
Fax: +65 6542 6920
mail@escoglobal.com

 


Basic Practices:
  1. Wash hands
  2. Wear a lab coat with knit cuffs
  3. Wear gloves
  4. Secure loose hair
Pre-compounding procedures
  1. Check whether the isolator was shut down completely by the previous user. The methods to verify proper shut-down and cleaning are
    • Check list
    • Sign-off
    • PC log
    • Tagging
  2. Check the gloves before starting for any breach because gloves are prone to wear
  3. Cleaning and disinfecting the unit before and after each use
Cleaning and Disinfecting HPI
  1. Using Wipers and Mops for Cleaning and Disinfection of Isolators
    • Wide variety of fabrics can be fashioned into wipers or mops
      • Natural materials: cotton, rayon and cellulosic
      • Synthetic materials: polyester, nylon, polypropylene or foams
      • Blends i.e. polyester-cellulose combinations
      • Polyester knit fabrics used for wipers and mop covers will not contaminate isolator surfaces - best choice for “non-linting” or “non-shedding” materials
    • Wipers can be wetted with:
      • Detergents to clean/disinfect the isolator
      • Deionized water or 70% IPA to remove cleaning agent/disinfectant residues

Cleaning and Disinfecting HPIs at the beginning of each shift

  1. Cleaning
    • Remove any residues and soils produced from the prior shift's activity using small flat surface mops, wipers, swabs and detergents
  2. Rinsing Following Cleaning
    • After cleaning, detergent residues are removed from the surfaces with wipers or mops that have been wetted with sterile deionized water or sterile 70% IPA
  3. Disinfection
    • The same procedures are followed for disinfection, except that liquid disinfecting agents are substituted for detergents i.e. quaternary ammonium compounds (“quats”)

Cleaning and Disinfecting HPIs at the beginning of each shift

  1. Rinsing Following Disinfection
    • After disinfection, disinfecting agent residues are removed from the surfaces with wipers or mops that have been wetted with sterile deionized water or sterile 70% IPA
  2. Gaseous Sterilization
    • If required, the isolator can be sterilized with a suitable sterilant such as Vaporized Hydrogen Peroxide (VHP)

Cleaning and sanitizing the interior of the HPIs between CSPs

  1. To avoid cross contamination between CSPs
    • The accepted procedure is to wipe the counter of the isolator with a wiper wetted with 70% IPA
    • Pre-wetted wipers are most convenient for this task
    • This will remove any residues from the work surface and will provide a measure of surface sanitization
  2. A final wipedown with IPA will leave the surface clean for the next CSP
  3. A second IPA-wetted wiper should be used to wipe down gloved hands to guard against cross-contamination in the preparation of the next CSP

Cleaning and Disinfection of Background Environments

  1. The USP <797> document requires that floors in the background environment be mopped daily, while walls, ceilings and shelving are to be mopped monthly

Aseptic Compounding

  1. Proper preparation of the compounds begin before the materials are put into the isolator
  2. Organize the necessary materials for compounding and placing them in the pass-thru chamber
  3. Wait until purging recovery time has passed  to transfer the materials
  4. Insert hands into the working portion of the gloves and open the inner door to move the items into the main chamber
  5. The inner door of the pass-thru unit is then closed
  6. In order to maintain ISO class 5 inside the chamber, the two doors should not be opened at the same time

Aseptic Compounding

  1. Recommended procedure is to wipe out the items after  removing them from the pass-thru chamber
  2. Technicians will verify the correct items are in the isolator for the work to be performed
  3. Compounding then can be done using appropriate aseptic technique
  4. Discard sharps in an approved sharp container after use
  5. Remove completed products via the pass-thru
  6. Label products before logging and delivery to patients
  7. Dispose trash after every procedure to reduce cross contamination to the products
  8. Compounding session is complete

Post-compounding procedures:

  1. Shut down the isolator completely.
  2. Sanitize the interior of the unit
  3. Remove any residual from previous compounds that were used in the isolator