Audit Report

Asahi Kasei Medical Co., Ltd. (Bioprocess Division) -Nobeoka

Audit #: JA - 800
Region: Nobeoka-shi Miyazaki
Material: Basic Chemicals/Raw Materials
Company: Asahi Kasei Medical Co., Ltd
Location: Planova Plant 6-4158 Asahi-machi, Nobeoka-shi Miyazaki 882-0847, Japan
Date: 15-16 November 2016

The scope of this audit included the manufacturing, testing and release activities associated
with the filters 15NZ-300 Planova 15N-Filterelements, 0,3 qm, EX4-0000 Filter Planova
BioEX 4m2, and EX1-0000 Filter Planova BioEX 1m2, as well as the AGP-HA 15S
Goldparticle solution AGP-HA15S.
As the manufacturing process for these filters is the same for the entire line of filtration
products manufactured at the Asahi Kasei Medical facility in Nobeoka, this report also can be
utilized as a report for all products manufactured there.
Planova N series filters
Type Surface Area (m2) Catalog No.
Planova 15N 4 15N4-000
Planova 15N 1 15F1-000
Planova 15N 0.3 15NZ-300
Planova 15N 0.12 15NZ-120
Planova 15N 0.01 15NZ-010
Planova 15N 0.001 15NZ-001
Planova 20N 4 20N4-000
Planova 20N 1 20F1-000
Planova 20N 0.3 20NZ-300
Planova 20N 0.12 20NZ-120
Planova 20N 0.01 20NZ-010
Planova 20N 0.001 20NZ-001
Planova 35N 4 35N4-000
Planova 35N 1 35F1-000
Planova 35N 0.3 35NZ-300
Planova 35N 0.12 35NZ-120
Planova 35N 0.01 35NZ-010
Planova 35N 0.001 35NZ-001
Planova 75N 1 75F1-000
Planova 75N 0.3 75NZ-300
Planova 75N 0.01 75NZ-010
Planova 75N 0.001 75NZ-001
Document Name: FORM 7 – Joint Audit Report Template Rx-360 Basic Chemicals and Raw
Materials_v2.0
Document Number: 2782252
THE INFORMATION GATHERED DURING AN AUDIT IS CONFIDENTIAL
Integrity test kit for Planova N series filters
Type Size Catalog No.
AGP-HA15 880 ml AGP-HA15M
AGP-HA15 110 ml AGP-HA15S
AGP-HA20 880 ml AGP-HA20M
AGP-HA20 110 ml AGP-HA20S
AGP-HA35 880 ml AGP-HA35M
AGP-HA35 110 ml AGP-HA35S
Planova BioEX filters
Type Surface Area (m2) Catalog No.
Planova BioEX 4 EX4-0000
Planova BioEX 1 EX1-0000
Planova BioEX 0.1 EXZ-1000
Planova BioEX 0.01 EXZ-0100
Planova BioEX 0.001 EXZ-0010
Planova BioEX 0.0003 EXZ-0003