Aseptic Fill Operations

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-99STekniSatTM Sterile, Pre-Saturated Polyester Knit4+
  • TekniClean 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 KnitTC2P99STekniCleanTM Sterile Polyester Knit4+
  • TekniClean 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

Other Pharmaceutical Applications