Extractables and Leachables Testing

Extractables and leachables are important indicators for risk assessment of SUS products, CTI Huatech can conduct extractables and leachables studies on disposable products including membranes, tubing, filters, and other components according to BPOG standardized extraction protocols or USP<665>, <1665>, and establish standardized databases for disposable system manufacturers to meet customers' needs, which can be used to guide the risk assessment of pharmaceutical companies. Risk assessment for pharmaceutical companies.

Final product quality control

SUS final products are usually tested for integrity, visual inspection, cytotoxicity, particulate matter, bacterial endotoxin, RNAase & DNAase, sterility, packaging and transportation confirmation, etc. CTI can conduct SUS product quality control according to USP<1207>, <87>, <788>, <85>, ISO11737, ISO10993, ASTM D4169 and other standards. D4169 and other standards for SUS end-product quality control, to facilitate rapid compliance and market launch.

Bacterial and Mycoplasma Challenges for Filters

CTI can conduct bacterial retention tests on 0.22μm filters/membranes according to ASTM F838 to verify whether the filters/membranes meet the requirements of sterilizing grade filters.
Filters with 0.1μm pore size accuracy can be used to address mycoplasma contamination in cell culture. CTI Huatech uses A. laidlawii (ATCC 23260) mycoplasma to challenge 0.1μm filters/membranes to validate the mycoplasma removal ability of the filters/membranes.

One-time system compatibility verification

The most prominent issue with the use of SUS products is the potential for compounds to leach from the contact surfaces of the SUS components and enter the process, thus negatively impacting the quality and safety of the drug product. Pharmaceutical regulatory agencies in various countries have set basic requirements for extractables and leachables from SUS.
CTI can conduct extractables and leachables studies on SUS products used in the processes of pharmaceutical companies in accordance with the requirements of USP<665><1665>, the Technical Guidelines for Compatibility Studies of Injectables and Plastic Packaging Materials for Chemical Drugs (Trial) and other regulations in China, and provide customers with compatibility study reports in compliance with the requirements of the regulations by combining with toxicology assessment and safety assessment.

Sterile Filtration Process Validation

Sterilization and filtration is a process that removes microorganisms from a fluid and should not adversely affect product quality. Sterilization filtration validation should include the performance validation of the sterilization filter itself and the filtration process validation, in which the filtration process validation is to validate the sterilization filtration process with respect to the specific fluid and the specific process conditions of the pharmaceutical manufacturing enterprise to ensure that the sterilization filtration process operates reliably under the predefined process conditions.
CTI Huatech can validate the sterilization filtration process, including bacterial viability, bacterial challenge, chemical compatibility, extractables and leachables, adsorption assessment, etc., in accordance with the requirements of the aseptic production guideline issued by FDA, PDA's Technical Report 26# Liquid Sterilization and Filtration, the domestic Guidelines for Sterilization and Filtration Technologies and Applications, and the new version of the GMP implementation guidelines for pharmaceuticals.

Virus Removal Validation for Virus Removal Filters

The purpose of the virus removal validation is to assess the ability of the manufacturing process to remove and/or inactivate known viruses. An appropriate amount of indicator virus is added to the sample, a scaled-down model is used to simulate the treatment of the sample with the process parameters, and then the virus titer in the sample before and after treatment is detected, and the virus removal effect of the production process is judged based on the titer reduction value (LRV).
CTI Huatech can design virus removal validation programs for different types of biologics according to customers' requirements, and use ATCC standard virus strains to carry out process validation of virus removal filtration, chromatography and other processes under various scaled-down models, so as to provide biopharmaceutical companies with research reports complying with regulatory requirements for the declaration and marketing of their products.

Radiation dose verification

CTI can carry out a full set of irradiation dose validation for irradiated sterilized SUS products according to the requirements of ISO11137 standard, and complete the regular audit of VDmax irradiation dose of SUS products according to ISO11737-1 and ISO11737-2.