Quality standard of compressed air for pharmaceutical use

Compressed air quality standards for pharmaceutical applications must be met at the same time. International Standards, pharmacopoeia specification and industry best practices the key control parameters and implementation requirements are as follows:

1. Core Standards Basis

1. ISO 8573-1:2010 (Compressed air quality classes)
   • solid particle:
     • level 1: particle size ≤ 0.1 μm, content ≤ 0.1 mg/m & sup3;(preferred for high-risk process).
     • Grade 2: particle size ≤ 1.0 μm, content ≤ 1.0 mg/m & sup3;(conventional pharmaceutical process).
   • Moisture (pressure dew point):
     • level 1: Dew point ≤-70 ℃ (special sterilization scenario).
     • Level 2: Dew point ≤-40 ℃ (automatic production line).
   • Oil content:
     • grade 1: ≤ 0.01 mg/m & sup3;(EU medical standard).
     • Level 2: ≤ 0.1 mg/m & sup3;(required by Chinese Pharmacopoeia).
2. Chinese Pharmacopoeia and GMP Requirements
   • oil content: clear ≤ 0.1 mg/m & sup3;, consistent with EU standard.
   • microbial control: Refer to clean room standards, such as ISO 5 (100) clean area, microbe ≤ 1CFU/m & sup3;.

2. Industry Practice Refinement Standards

1. selection of drying method
   • adsorption dryer: The dew point can reach -40 ℃ to -70 ℃, which is suitable for scenes with high degree of automation and intensive instruments.
   • Two-stage drying (freeze adsorption): Used in high humidity areas to ensure dew point ≤-20 ℃.
   • Validation cycle every 6 months to detect dew point, oil content, particle number, in line with ISO 12500 standards.
2. Filtration System Configuration
   • three-stage filtration:
     • pre-filter coarse (3 μm) precision filter (0.01 μm) sterilization filter (0.22 μm).
     • The oil mist separator shall achieve a removal efficiency of 0.01ppm.
   • End Guarantee: Sterile grade filters (0.22 μm) are used in processes that directly contact pharmaceutical products.
3. Piping and Material Requirements
   • compressed air contact part: Using 316L stainless steel to avoid carbon steel corrosion pollution.
   • Inner wall treatment: Electrolytic polishing to Ra≤ 0.4 μm to reduce particle shedding.
   • Pipe rack isolation stainless steel pipe and carbon steel bracket shall be padded with insulating material to prevent potential difference corrosion.
4. On-line monitoring and verification
   • key node installation of dew point meter, oil detector, real-time warning.
   • Periodic verification every 6 months for dew point, oil content, particle number testing, in line with ISO 12500 standards.

3. special scene requirements

1. aseptic filling area
   • add steam sterilization system, air blow 30 minutes after high temperature steam sterilization.
2. Cryogenic Laboratory
   • the dew point of the dryer shall be 10 ℃ lower than the lowest ambient temperature to prevent freezing.

4. Compliance Implementation Recommendations

1. system Design: Adopt oil-free air compressor adsorption dryer three-stage filtration combination, and the end is equipped with sterile filter.
2. Verification file record the whole process data of installation confirmation (IQ), operation confirmation (OQ) and performance confirmation (PQ).
3. Risk control risk assessment of compressed air system shall be carried out regularly and control measures shall be updated.

The combination of these standards and practice ensures that compressed air for pharmaceutical use complies oil-free, dry, dust-free, sterile requirements to ensure the quality and safety of drug production.