N.35 – CERTIFICATE OF CONFORMITY

TRIO

The TRIO.BAS  air samplers:

fulfil the requirements of:

· ISO Standard 14698-1 – 2004 Guidance for Industry on Sterile Drug Products by Aseptic Processing – Current Good Manufacturing Practice

· FDA – 1987 Guideline on Sterile Drug Products by Aseptic Processing

· ACGIH – Guideline for Assessment of Bio-aerosol in the Indoor Environment

· ASTM – Draft Protocol – Committee D22.05.06

· USP Chapter <1116> Microbiological Evaluation of Clean Rooms and Controlled Environments

· EU Guide for GMP – Manufacture of Sterile Medicinal Products Control Medicines and Inspection

ORUM International S.r.l. – Microbial Air Sampling Division

Via Novara 91 20153 – Milan, Italy

Roberto Ligugnana – President

TRIO.BAS-BOTTON-005