Reliable cGMP Compliance is Essential to Managing Risk

In the interest of safety, purity, and effectiveness, pharmaceutical manufacturing industries must comply with the FDA’s Good Manufacturing Practices (cGMP). Validation is a critical part of ensuring that regulations are followed and the costly consequences of non-compliance and risk of cross-contamination are avoided.

APPLICATIONS

  • Cleaning and disinfecting a wide range of production equipment surfaces and components
  • Cleaning and eiliminating disinfectant and API residuals from surfaces

CRITICAL CHALLENGES

  • Assuring cleaning SOPs and cGMP practices are followed correctly
  • Removing residuals and bioburden efficiently
  • Maintaining sterile processing conditions during cleaning and processing

Recommended Cleaning Solutions for Aseptic Fill Operations

Product FamilyPart #MaterialISO LevelProcess Benefits
TekniGamma PolypropyleneTS2PUI70P-99STekniPure Sterile, Pre-Saturated Polyester Knit4+
  • TekniPure polyester wipers are the "gold standard" for cleanliness, abrasion, and chemical resistance
  • Meets ANSI/AAMI/ISO 11137-2: Sterilization of Health Care Products - Establishing the sterilization dose via Method Vdmax
TekniGamma Polyester KnitTC2P99STekniPure Sterile Polyester Knit4+
  • TekniPure polyester wipers are the "gold standard" for cleanliness, abrasion, and chemical resistance
  • Meets ANSI/AAMI/ISO 11137-2: Sterilization of Health Care Products - Establishing the sterilization dose via Method Vdmax