Services

Our global services

Our global network of technical support team is always responsive in providing solutions to optimize customers' processes. In order to meet customers' needs, we are driven to apply our technical expertise in maximizing the potential of our unique technology in the fields of virus removal filtration, impurity removal and bioprocess related equipment. Not only do we integrate ideas coming fromall across our global network; but we also act locally to be as close as possible to our customers.

Global support bases

Global support bases Our locations

Bases of operation in Japan

Bases of operation in Japan

Audit Reports Availability

Asahi Kasei Medical Co., Ltd. is pleased to inform that audit reports for Planova Plant and Planova Oita Plant are now available for purchase from Rx-360, an international pharmaceutical supply chain consortium.

Purchasing these audit reports allows biopharmaceutical companies to obtain audit reports for Planova manufacturing facilities without having to conduct the audits directly, which could potentially help to save time and costs. Other features and benefits of purchasing the audit reports are as follows:

• Companies could save time and cost of traveling to Miyazaki and Oita, Japan.
• Companies could save cost and labor of contracting third-party auditors to conduct
in Japan.
• Both FDA and EMA accept audits conducted by third-party auditors, including these
reports.
• Reports can be purchased by Rx-360 members or non-members.
• Companies from countries and regions such as China, India, Russia, Israel, Southeast
Asia, Latin America, the Middle East and Africa could obtain the audit reports without
limitations due to export control, as the reports do not contain regulated technical
information.

The audit reports for purchase from Rx-360 are available from the following URLs:

• Audit Report for Planova Plant (located in Nobeoka-shi, Miyazaki, Japan):
http://rx-360.org/audit-program/asahi-kasei-medical-co-ltd-ja-800

• Audit Report for Planova Oita Plant (located in Oita-shi, Oita, Japan):
http://rx-360.org/audit-program/asahi-kasei-medical-co-ltd-ja-801

The scope of the audit reports includes the manufacturing, testing and release activities associated with products manufactured at each facility as outlined in the table below.

Moscow01



Please note that customers purchasing Planova or Planova BioEX may receive filters manufactured either in Planova Plant or Planova Oita Plant, and thus may need to purchase audit reports from both plants.

More information purchasing audit reports from Rx-360 can be found in the following page: http://rx-360.org/audit-programs/purchase-audit-reports/
Should you have any questions regarding these audit reports, please contact your local Planova representative. We thank you for your continued support of Planova.





Consumables

Using our more than 20 years of virus filtration experience and innovation in bioprocess technology, our technical experts assist customers to achieve process economy and efficiency as projects progress from process development to virus validation and finally to full scale processing.

On-site support

Lab scale

We conduct lab scale trials at customers’ sites whenever requested. Since we provide all the necessary instruments for these trials, customers only need to prepare protein sample solutions. Based on the resluts of these lab scale trials, we can estimate the required membrane surface area needed for commercial production scale processes and can determine the optimal conditions for the achievement of process economy and efficiency.

Clinical scale

We provide installation support for the larger sizes of our bioprocess consumables when processes are being scaled up. At this scale, process automation can be achieved using the standard or custom skids we offer. In addition, we also support customers’ virus validation studies at contract laboratory organizations (CLOs).

Commercial scale

We help customers achieve process optimization via our automated skid systems and our staunch technical support. We also conduct on-site trainings whenever requested.

Off-site support

Lab & clinical scale

We periodically hold trainings and seminars for our customers at our training sites in order to help optimize product usage. Also, our annual workshop provides customers with an opportunity to share information related to product usage, technology updates and new applications with other users.

Commercial scale

We provide required technical and quality-related information in a timely manner through quality questionnaires, audits, documentation and customer notifications.

Equipment

Our engineering and technical support teams offer creative solutions through intense customer collaboration to ensure optimization of customers' processes throughout the various process stages.

  • Preventive maintenance
  • Instrument verification and calibration services (specifically for Asahi Gold Particle Test System)
  • Contracted service (scheduled maintenance, spare parts, emergency response, automation/software support)
  • Qualification services, such as equipment IQ and OQ
  • On-site commissioning and Site Acceptance Testing (SAT)
  • Operator training
  • Onsite column packing and unpacking support
  • Product demonstrations at Asahi Kasei Bioprocess facility (Glenview, IL, USA)
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