Moisture Analysis & Titration at Ohara Pharmaceutical Co., Ltd.

Ōhara Pharmaceutical Co., Ltd., with three factories and two research laboratories based in Kōka City, Shiga Prefecture, is a pharmaceutical company committed to the research and development of high-quality, affordable generic drugs
and orphan drugs, particularly for pediatric cancer. In its role as a member of society and Kōka, the company conducts community outreach activities in Kōka City, particularly those centered on supporting children. Among the many tools supporting the important work of Ōhara Pharmaceutical Co., Ltd. are approximately 20 KEM analyzers, primarily Karl Fischer moisture analyzers and titration systems.

　　

　

Interviewees:
Mr. Ōta, Factory ‘A’ QA Manager
Mr. Takeda, Factory ‘B’ QA Manager

KEM: First let me thank you as always for your patronage. Now for my opening question, could you please tell me a typical scenario requiring moisture content analysis at Ōhara.

Mr. Ōta: Well, for example, we employ KEM’s KF moisture titrators at least 3 times a week for analyzing raw ingredients to confirm that their moisture levels are in line with the values stated on their labels.

KEM: Ōhara has introduced multiple KF moisture titrator units to its laboratories. What makes it necessary to have so many?

Mr. Takeda: Perhaps the main reason is that it is bothersome to have to constantly change Karl Fischer reagent for different tests. We test many types of sample, with each requiring a different reagent, so we have units dedicated for use with specific reagent types. We also dedicate units for other purposes such as for the measurement of specific moisture ranges, which explains our adoption of multiple units. Another reason is that we conduct testing in multiple factories, requiring dedicated units for their respective measurement environments.

KEM: Thanks for the insight and your kind patronage. Please share your honest impressions or experience as a customer of KEM’s KF titrators.

Mr. Takeda: We request inspections (editor’s note: inspections include calibration) twice a year, so whenever we encounter result value discrepancies, we proceed with the assumption that the instrument is functioning correctly.

KEM: Are you saying that discrepancies originate from how the user performs measurement and/or instrument operation?

　

Mr. Takeda: Yes, that’s most often the case. The causes often stem from areas that haven’t been standardized, such as the timing of material unpacking. In the pharmaceutical industry, it’s more than 99% unlikely that the raw materials themselves are the issue.

KEM: You both must have had your fair share of difficulties with that aspect when you were personally conducting analyses, correct?

Mr. Ōta: I’ve been with the company for 17 years, and Mr. Takeda for 13, and the whole time we’ve been here, we’ve used KEM KF moisture titrators. Yes, there were definitely times when we encountered data discrepancies resulting in us being stuck in the lab all day to figure them out! (laughs)

KEM: Since joining the company, you say… we’re truly honored to have had such a long-standing relationship with you. If I’m not mistaken, your experience using KEM moisture titrators spans the last three generations. Compared to earlier models, are there any improvements that stand out, or any aspects of concern?

Mr. Takeda: To start, they have successively become easier to operate. The newest burettes have excellent moisture contamination prevention. Having said that though, we would like to see the burettes become easier to clean. We would also like it if you could make it easier to remove the grease from the cell’s sample inlet.

KEM: Thank you indeed for your invaluable feedback. We will take these comments on board to inspire the development of future models and to further enhance our services. Thanks for the insight and your kind patronage. We look forward to helping you into the future.