Core requirements for chemical equipment in the production of biological peptides
The production of biological peptides involves the synthesis and purification of bioactive substances, which have special requirements for chemical equipment in terms of material safety, hygiene design, and process adaptability
Material safety and corrosion resistance
Components that come into direct contact with materials should be made of 316L stainless steel or titanium to avoid metal ion contamination (such as copper peptide production requiring prevention of copper ion precipitation)
The sealing material must comply with FDA/EU standards to prevent leakage caused by organic solvents or acid-base corrosion
The surface needs to be electrolytic polished to reduce the risk of microbial growth (GMP requirement Ra ≤ 0.4 μ m)
Sanitary Design Standards
The equipment structure should have no dead corners and support CIP (online cleaning) and SIP (online sterilization) systems
The pipeline adopts sanitary valves to avoid blind pipe design and ensure complete emptying of materials
Solid liquid separation equipment such as filter presses should be equipped with detachable filter cloth to prevent cross contamination
Process adaptability
The enzymatic hydrolysis reaction tank needs to have a temperature control accuracy of ± 0.5 ℃ and automatic pH adjustment function to ensure the directional cleavage of peptide chains
The ultrafiltration system needs to use membrane components with a cut-off molecular weight of less than 1kDa to meet the separation requirements of small molecule peptides
The spray dryer needs to control the inlet air temperature ≤ 80 ℃ to prevent the deactivation of thermosensitive peptide 3
Compliance certification
Pharmaceutical grade equipment must pass GMP certification, and food grade equipment must comply with HACCP standard 1
Pressure vessels must be designed in accordance with GB150-80 standards and obtain a special equipment license