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Feature: Pharmaceutical Compounding Technote
 
Pharmaceutical Compounding

The objective of USP <797> is to describe conditions and practices to prevent harm, including death, to patients that could result from:
  • Microbial contamination
  • Excessive bacterial endotoxins
  • Variability in the intended strength of ingredients
  • Chemical and physical contaminants
  • Incorrect type or quality of ingredients in Compounded Sterile Preparations (CSPs)

    USP <797> provides practice and quality standards for all persons who prepare CSP drugs and nutrients and all places they are prepared.

    USP <797> requires that the preparation of CSPs occur in ISO Class 5 (Class 100) environments, buffer areas of ISO Class 7 (Class 10,000), and ante-areas of ISO Class 8 (Class 100,000). Achieving and maintaining cleanroom environments requires new procedures and protocols.

    ITW Texwipe® has been the cleaning technology leader in controlled environments for more than four decades. We have the advice, tools and products for such USP <797> requirements as:
  • Cleaning ISO Class 5 surfaces every shift
  • Cleaning counters, work surfaces and floors daily
  • Cleaning walls, ceilings and shelves monthly
  • Cleaning supplies while transferring them to clean areas
  • Cleaning spills
  • Spraying and wiping gloves throughout the shift
  • Cleaning supplies in the controlled environment
  • Cleaning validation

    These products are available through a network of specialty distributors and supported by the ITW Texwipe technical support.

    A pdf brochure for this industry can be found here.

  • Dry Wipers
    • Blended Nonwoven Wipers - Hydroentangled, polyester/cellulose blends for use in areas where moderate contamination control is required
    TechniCloth® - TX609 and TX612
    VersaWipe® - TX622, TX624 and TX629

    Synthetic Wipers - Cut, laundered and cleanroom packaged wipers for critical environments
    AlphaWipe® - TX1004, TX1009 and TX1013

    Vectra® Process Sealed-Border Wipers - Ultraclean, sealed-border wipers for the most critical environments
    Vectra® QuanTex™ - TX1080

  • ITW Alma Products
    • Contamination Control Mats - Adhesive-coated mats that capture particulates from foot-traffic and equipment wheels before they can get tracked into the cleanroom
    CleanStep™ Contamination Control Mat External link
    FirstStep® Contamination Control Mat External link

  • Mops
    • AlphaMop™ - Polyester mop system for the easiest and most efficient cleaning of floors, walls and ceilings
    AlphaMop™ - TX7108

    AlphaMop™ Isolator Cleaning Tool - Cleaning system for isolators, biosafety cabinets and laminar flow hoods
    AlphaMop™ Isolator Cleaning Tool - TX7101

    Mini Environment Cleaning Kit - Cleaning kit designed to facilitate the cleaning of isolators, laminar flow hoods, glove boxes and biosafety cabinets
    Mini Environment Cleaning Kit - TX7401

  • Pre-wetted Wipers
    • Cleanroom Pre-wetted Wipers - Wipers pre-wetted with cleaning solutions and packaged in a variety of convenient dispensers for use inside and outside the cleanroom
    PolySat® - TX1051
    TechniSat® - TX1041, TX1045 and TX1065

  • Solutions
    • Sterile Alcohol - Specifically formulated alcohols for high-performance cleaning in sterile environments
    Sterile 70% Isopropanol - TX3270 and TX3290

  • Sterile Products
    • Sterile Dry Wipers - Developed to clean aseptic cleanrooms, without compromising the sterile nature of those environments
    Sterile TexTra™ - TX3220
    Sterile TexTra™ 10 - TX3224 and TX3225
    SterileWipe™ HS II - TX3210
    SterileWipe™ LP - TX3211
    SterileWipe™ LP 10 - TX3212

    Sterile Pre-wetted Wipers - Sterile wipers pre-wetted with 70% isopropyl alcohol (IPA) and deionized water (DIW)
    Sterile AlphaSat® 10 with WFI - TX3280
    Sterile PolySat® - TX3213 and TX3216
    Sterile TechniSat® - TX3214 and TX3217

  • Swabs
    • Absorbond® Series - Hydroentangled continuous filament polyester heads. 100% virgin polypropylene handles.
    Absorbond® Swab with Long Handle - TX762

    Alpha® Series - Cleanroom laundered 100% continuous filament knitted polyester heads. 100% virgin polypropylene handles.
    Large Alpha® Swab - TX714A
    Small Alpha® Swab - TX743B

    High-Sorbency Series - Cotton tip heads with wooden handles
    Wrapped Cotton Swab - TX705