Classical Pharmaceuticals
Small Molecule Manufacturing Expertise

Ease of Use and Flexibility with Single-Use

Single-use technologies reduce manufacturing time and costs by eliminating cleaning and validation steps. Along with these benefits, however, come new considerations including chemical compatibility of plastic components and the shift of critical validation strategies from the end-user to the supplier.


1. Optimize Your Sterile Sampling Methodology


More stringent validation requirements and increased use of Quality by Design (QbD) and Process Analytical Technologies (PAT) demand greater scrutiny of sampling processes. Traditional sampling methods do not meet the expectations of regulatory authorities due to the risk of contamination through open ports in the manufacturing system and the potential for operator error.

Solution

Implementing an optimized sampling process reduces risk and increases productivity. Learn how sterile sampling systems reduce the potential for contamination and how good sampling practices can be used to monitor filter effectiveness and assess process and product quality.

2. Assess the Chemical Compatibility of Your Single-Use Components


Single-use equipment is typically manufactured from polymeric materials. Process fluids, depending on their chemical composition, might negatively interact with these polymers. The challenge is finding materials of construction which are compatible with your raw materials and process streams. Moreover, it is often difficult to find detailed guidance on the steps needed to demonstrate chemical compatibility. Regulatory and guidance documents cover a wide variety of products and processes and do not provide detail on specific methods or procedures.

Solution

Proper selection and qualification of single-use equipment and materials for pharmaceutical manufacturing should include a thorough assessment of the chemical compatibility of the product contact components.

It is important to partner with a supplier who:

  • Understands your process and has an in-depth knowledge of single-use materials
  • Assists in assessing process risks, and provides recommends on how to appropriately mitigate those risks.

Learn more about the selection and qualification of single-use in manufacturing.