REGULATORY TESTING SERVICES
1.0 "European Pharmacopeia (Ph. Eur.) 2020" Cultural Testing according to the Test Requirements in Ph.Eur. 2020 : 10.0 MYCOPLASMAS (28 days test)
1.1.1 Combined Culture and PCR Test
1.1.2 Test for Inhibitory Substances (Stand Alone)
This test should be carried out initially or when there is a significant change in production method.
1.1.3 Test for Inhibitory Substances (inclusive)
Added to 1.0 or 1.1.1 when the stand alone test has not been previously carried out.
1.1.4 Test for Absence of Non-
AMERICAN VETERINARY PROTOCOL
2.0 USDA 113.28
JAPANESE VETERINARY PROTOCOLS
3.0 Minimum Requirements for Biological Products for Animal Use of Japan (MRBPAU)
NOTE: All media lots used in the above tests are validated with vero maintained M. hyorhinis cultivar α .
HUMAN VACCINES AND BIOLOGICALS
4.0 Mycoplasma Experience can fulfil the requirements of all International Protocols e.g. FDA "Points to Consider" & 21 CFR Ch.1 Para. 610.30.
Please request a quotation specifying the protocol with which your products must comply.