EXPLORER NEWS – IMPROVING YOUR EFFICIENCY

Market Regulation

Food, beverage, and pharmaceutical manufacturers have created a high-level production process defined by internal standard operation processes (SOP) and local and global regulations (USP) in order to better control the quality control process. Massive production demands have created the need for operators to be trained, and have the skillset, and knowledge to operate the assigned workstation. To minimize and reduce the impact of human error, factories are looking for useful tools to improve production efficiency.

Weight Variation Process

The tablet press machine is an automatic, continuous rotary tablet press that is widely used in the pharmaceutical, chemical, ceramic, food, electronics, plastics, and powder metallurgy industrial segments. It is utilized to press granular raw materials into tablets. After tablets have been produced, the operators are assigned to check the weight periodically to ensure that the batch sample quality meets specifications.

According to the handbook *USP905 (Exhibit 1) and*USP2091 (Exhibit 1), separate and distinct procedures and limits are described for capsules, uncoated tablets, and coated tablets.

Example:

In a typical application involving a weighing station or workshop, the operators conduct weighing during batch tablet testing. Every 15 to 20 minutes, operators must consider the total weight of 20 units and manually calculate the average weight of the batch. The purpose of the calculation is for the operators to compare the weight of the individual tablets and to ensure that they have not exceeded the set standard or defined criteria.

Based on different SOPs, some enterprises still utilize traditional methods of handwritten sample weights on the tracking sheets or print records. At the end of the process, they manually calculate the average tablet weight, total weight, and differentiation percentage.

Some advanced level enterprises use SQC (statistic quality control) mode to preset a Nominal variation weight for batches. The difference between pre-defined weight with actual variation weight might be minimal, but it is more accurate to do it individually.

Fill Weight Variation

With the newly released EX2.20 software, the OHAUS EXPLORER Series has a dedicated application mode for "Fill Weight Variation". It helps calculate statistical information and reduce the risk of error on manual calculations and/or pre-defined nominal weight. It is also capable of publishing criteria into the final report.

Example:

In this weighing workshop, operators are required to test to ensure that the tablets weigh in-between a range of 130mg to 324mg.

• First, the operator sets the parameters in the software according to *USP2091 (Exhibit 2), where the acceptable difference is ±7.5%.
• Calculate the average weight of 20 units. Once the average weight is defined, the operator is able to view the weight of individual tablets to determine if it falls in the "Accept" or "Under and Over" color block.
• EXPLORER balances provide print data categories that include:
  • Individual weighing data
  • Differentiated percentages between average weight with single weight.
  • Quantity of Accept/Fail units
  • Average weight, Limit %

Before

After

Exhibit 1
Chapter	Name	Reference
<905>	UNIFORMITY OF DOSAGE UNITS	Available from Stage 6 Harmonization. Copyright (c) 2011 The United States Pharmacopeial Convention. [December 1, 2011]
<2091>	WEIGHT VARIATION OF DIETARY SUPPLEMENTS	Available from 978 <2040> Disintegration/Dissolution / Dietary Supplements. Copyright (c) 2011 The United States Pharmacopeial Convention. [May 1, 2012]

Exhibit 2
Chapter	Name	Criteria
<2091>	WEIGHT VARIATION OF DIETARY SUPPLEMENTS

Learn more about Explorer balance and its updated software function at www.ohaus.com/Explorer