Challenge the Future
with Regulatory Compliant Balance
Shimadzu has just added three high-sensitivity semi-micro analytical balances to its AP-W series lineup. The new models, AP135W, AP125WD, and AP225WD, feature a minimum reading of 0.01 mg (1/100000th of a gram). With these models, the AP Series product family now includes: Semi-Micro Series, Advanced AP-W Series, Standard AP-X Series and Standard AP-Y Series, catering to a wide range of weighing requirements.
General Manager Weighing Instruments Business Unit, Analytical and Measurement Instruments Division, Shimadzu Corporation.
In 2013, a pharmaceutical customer asked us, "Can't you make it faster?" The customer explained that the response time of our balances was about ten seconds from sample setting to test result. At the time we launched our previous model, ten seconds was not too slow; however, the need for faster response continually increases due to the high productivity requirements in labs these days. During the early stages of drug discovery, scientists are loaded with samples to weigh; at times, the number of samples can be in the thousands. At ten seconds per sample, users have to spend extraordinarily long times with this task. We wanted to solve their problem! We decided to develop ‘Fast and Stable’ balances for the benefit of our customers. Our development team spent a considerable amount of time studying the older designs of balances in order to engineer a balance that offers the optimum balance of speed and performance while adding several new innovations not available elsewhere.
One of the major challenges designers of balances encounter is the miscellaneous noise generated from internal electronic circuits, which can affect sensors and decrease the measuring speed and accuracy. The higher the noise, the more difficult it is to distinguish digital signals resulting from loading or from noise by electronic parts, meaning it will take more time to complete the measurement. Extensive research for more than eight years at Shimadzu has focused on addressing this challenge. Before starting the development of this new series, we checked rigorously even the slightest noise in every single IC tip and worked extensively to find the best combination with different characteristic parts and components. After tremendous research and experimentation, we finally reduced noise to less than half of previous models.
Decreasing noise was not the only objective. Developing data processing technology to distinguish weight signal from external disturbance was of paramount importance. This is called Filtering (Smoothing) and the Signal processing technology developed by the Shimadzu Technology Research Laboratory was utilized. This technology can distinguish slight differences between digital signals by loading from noise quickly and precisely. As a result, the filtering (smoothing) speed was greatly improved, which played an important role in the development of high-speed weighing balances.
New Weighing Sensor, UniBloc AP
Settling the drift* was also one of the most important challenges in the development of these balances. We reviewed materials used in the current UniBloc and found that one of them was commonly affected by humidity. Humidity is a big factor contributing to unstable weighing values. The new UniBloc AP weighing sensor offers has a high resistance to humidity to allow more accurate and precise measurements.
Drift*: Display value keeps increasing or decreasing gradually.
With three technologies
Our steady efforts to reduce noise from internal electronic circuits and the introduction of the latest ‘filtering technology’ utilizing signal processing technology have resulted in amazing response speeds in the new models, which are especially useful for trace measurements. The new UniBloc AP balances with humidity resistance allow more precise and accurate measurement with less stress on the operator.
Increasing Laboratory Productivity
At the same time as the component technology development, we also conducted extensive market research. We found a big demand from scientists for the removal of ‘static electricity’. In drug discovery, scientists have to control infinitesimal weights to ten‐thousandth of a gram. Static electricity affects the sample weights and is a constant source of headache during the weighing processes, and can even be worse than the noise problem. To alleviate this issue, we developed the new ionizer, STABLO-AP. With the high-frequency *AC corona discharge method, STABLO-AP ionizer provides a stable ion balance and excellent static removal performance on samples and containers, enabling remarkably efficient precision weighing. Electrodes used in this design, are safely housed inside the unit.
*AC corona discharge method: AC voltage is applied on the discharge needle and a well-balanced mixture of positive/negative ions is emitted in rapid alternation from one electrode.
Customers can use the STABLO-AP as hand-held/built in. This unique 2-way positioning adds flexibility. Our balances coupled with STABLO-AP have been found to be an essential requirement during the sample preparation steps while using the Shimadzu GCMS PY-Screener.
Easy-to Read, Easy-to Use
Meanwhile, we received some demands for user-friendly functions from quality control departments in the automotive and food industries. For field operators and novice users, our previous interface was seen as too complicated. It was really difficult to understand the icons of functions. To achieve more intuitive operation, our new balances adopt a high-visibility organic EL display with three language selections: English, Japanese, and Chinese. (We are now working on other languages.) Of course, touch-screen display was one of the choices, but we chose the above organic EL display for improved usability. The screen can be seen clearly even in dark locations, and a wider viewing angle (±85 degrees) has also improved the visibility of measurement values, which helps increase the efficiency of measuring operations. With these functions, everyone can use the balances without an operation manual. We are confident that this organic EL display will improve a user`s working conditions.
The USB connector allows a commercially available USB keyboard or barcode reader to be connected to the main unit, enabling data to be saved directly to a USB flash drive. Registered sample names or IDs can be associated with measurement values for highly convenient data management.
Total Shimadzu Solution
We want to offer ‘only one solution’. For HPLC users, we have developed a ‘buffer solution function’. HPLC users need to often calculate the pH level of mobile phase solutions This process takes a lot of time and effort. Moreover, there is a risk of miscalculation. The buffer solution preparation function will help in such a situation. This function shows the substances to measure and their weights in accordance with registered recipes, and can automatically calculate the weight values required to prepare solutions with specified concentrations. The balances are pre-registered with recipes for the 13 buffer solutions used most frequently with HPLC, thereby making pre-analysis work more efficient. Users do not have to calculate by themselves! We can do that precisely and accurately, since only Shimadzu can offer both HPLC and Balances.
Regulatory Compliance Balance
Solutions to improve operational efficiency and ensure data reliability
During our market research, we found out that Regulatory Compliance is the most important consideration for pharmaceutical customers. By collaborating with the Shimadzu software development team, we were able to launch LabSolutions Balance for Regulatory Compliance. When connected to AP series balances as well as AU, AT and UW/UX series balances, LabSolutions Balance workstation can be used to perform all processes automatically, such as calculating results and saving weighing results in a LabSolutions database. Consequently, it eliminates the need for handwritten records and eliminates transcription errors. The software not only records sample information but saves and protects data from malicious alteration and unintended overwriting or deletion, and saves all audit trail information in the LabSolutions database. Furthermore, balance measurement data can be loaded during LabSolutions LC/GC batch analysis to create user-customizable analysis reports or for integrated data management by connecting to a LabSolutions CS integrated network system that includes non-Shimadzu products.
In addition to improving efficiency and reliability, this is an ideal product for customers who require measurement results traceability and compliance with FDA 21 CFR Part 11 or other regulations. Finally, we are under the same umbrella with Shimadzu’s other analytical instruments.
Minimum Weighing Value Function for USP is also a big demand from pharmaceutical customers. The minimum weighable value is very much dependent on the installed environment. By following the instructions (and using the designated weights), the AP series can auto-calculate the ‘weighable minimum weight’ in the installed environment. The value will be recorded. When users start weighing, if the weight of a sample is less than the set minimum weighing value, the balance gives a warning.
Proper Record Format for GLP/GMP
Users can output data to a computer or as a recorded slip with the optional printers, EP-100 and EP-110. These printers can be customized.
ID/Password Function for Compliance.
AP series allows managing users with different authority by ID/Password. With the above features and the option to work under the LabSolutions environment, we are sure all pharmaceutical customers will appreciate the vast capabilities built into our Regulatory Compliant Balance.
Still On Our Way
Having worked on the development of the AP series for almost three years (and more years for the component technology development), we are very excited about the release of the series, including the semi-micro models. We have already have received positive feedback from a number of customers in Japan and from international regions regarding the ‘fast response’ and many useful functions. However, as trends and expectations continue to evolve, we are inspired to do more development based on our customer demands. At Shimadzu, we want to offer only the best for our customers, and our commitment will always be to address the challenges and needs at our customers’ labs.