AUSTAR Assists a Leading Pharmaceutical Company in Successfully Completing Deficiency Remediation Efforts

Project Background: 

A renowned pharmaceutical company, which had passed FDA inspections five consecutive times and obtained FDA marketing authorization for 12 generic drug products, received an FDA warning letter in July 2024. The letter highlighted insufficient facility design, particularly inadequate contamination prevention measures in areas producing sterile products. Additionally, the FDA noted risks to sterility due to the transfer of drug-contact equipment and tools through open transition zones (Grade A/B) after sterilization.

AUSTAR Solution:

• FMS Retrofit Based on CCS (Contamination Control Strategy): Upgraded facility management systems (FMS) to align with contamination control requirements.

• Gap Analysis and Safe Cross-Grade Transfer: Introduced flexible breathing caps and autoclavable breather bags to ensure sterile transfer of drug-contact equipment across cleanroom classifications.

• Isolator Filling Line Retrofit with RTP Integration: Modified isolator filling lines by integrating Rapid Transfer Port (RTP) valves and implementing a Beta transfer solution to achieve containment and sterile transfer of rubber stoppers.

  

AUSTAR Value and Client Benefits:

• Provided on-site retrofits, sterilization packaging solutions, and customized sterile consumables for critical material transfer, unpacking, and installation.

• Replaced traditional laminar flow cart transfer methods with flexible breathing caps and autoclavable breather bags, aligning with EU Annex 1 requirements for sterile transfer risk control.

• Reduced the production environment from "Grade B + A” to “Grade C + A” through isolator filling line retrofits, lowering energy costs and maintenance efforts.

• Delivered a tailored Beta transfer solution, including transfer protocols, bag design, sterilization process optimization, and fill volume validation.

• Accelerated validation cycles and enhanced sterile transfer efficiency through expert guidance.