Process filtration for API production

Producing active pharmaceutical ingredients is one of the most sensitive and tightly controlled areas of pharmaceutical manufacturing. Each batch brings its own challenges, whether working with aggressive solvents, reactive acids, or highly potent compounds that require complete containment at every step. In these conditions, pharmaceutical filtration systems become more than a process step; they are safeguards that protect people, products, and the environment.
 

From the first drop of ingredients water to the final fill, every filter in the API line plays a distinct role. Depth and particulate filters capture visible contaminants early, stabilizing feed quality and protecting downstream stages. Bioburden-reduction membranes lower microbial load before formulation, while sterilizing-grade filters provide the final barrier that ensures absolute product purity. Vent filters on tanks maintain closed systems, allowing safe air exchange without risking microbial ingress.
 

By combining these layers of protection with validated, high-quality materials and designs that meet global standards such as ISO 9001 and FDA CFR Title 21, manufacturers achieve consistent purity, GMP compliance, and process reliability. Each solution is engineered for safe, efficient, and long-term performance, ensuring every active ingredient meets its intended quality and safety requirements.
 

The process map below shows how process filtration supports every stage of API manufacturing, from pretreatment and storage to formulation and final handling, keeping both quality and safety in balance throughout production.

Atlas Copco provides robust solutions that withstand aggressive chemistries while maintaining sterility and integrity or your products. Our solutions include: 

• PFP⁺, PFP⁺ A, and PFP⁺ D PP filters: 
  Used for prefiltration to remove particles and protect downstream sterile-grade filters, and to stabilize the process during solvent filtration and crystallization. 
  
• SMT-G PTFE filters: 
  Applied as vent filters on storage and formulation tanks, preventing microbial ingress and maintaining sterile air exchange.
  
• PFP⁺ A PP filters: 
  Provide reliable particulate removal before formulation and final stages, ensuring clean input streams.
  
• BME⁺ PES filters: 
  High-efficiency bioburden-reduction membranes used just before final fill/hold to lower microbial load and protect the sterilizing grade filter.
  
• SME⁺ PES filters: 
  Optional sterilizing grade membranes used when a sterile API is required immediately before filling.

Together, these filters safeguard the entire API production line, from ingredient preparation through formulation to final product, ensuring consistent purity and compliance with pharmaceutical standards.