Manufacturing execution software
From Wikipedia, the free encyclopedia
MANUFACTURING EXECUTION SOFTWARE for Pharmaceutical, Cosmetic, Flavor and Fragrance, Nutraceutical, and Specialty Chemical Companies by *Valdata Systems Inc.
The MES system is a real time, totally paperless program that uses a network of radio frequency (RF) connected computer workstations, with touch screen input. It supports bar code scanners and printers and scales that directly interface to the workstations.
The MES system uses Microsoft SQL as its database. The SQL server is ODBC compliant and any SQL compliant software such as MS Excel, MS Access, and Crystal Reports can access the data produced in the system. The system is fully secure and it meets the demanding FDA 21 CFR Part 11 requirement for secure electronic data storage and electronic signature acceptance.
The system prompts and then polices employees to perform their jobs, following the company’s standard operating procedures. The system has the ability to validate the accuracy of the data it collects as it is produced. It eliminates the paperwork that is normally required in manually controlled systems.
The MES software controls and documents the pre-weigh formula dispensing, mixing and blending and bulk material pack-out activities. These are the Work-In-Process areas that are normally hard to track and record.
Once the production requirements have been scheduled in the ERP system, they are automatically downloaded to the manufacturing execution module. The system then takes full responsibility for controlling the manufacturing process to within control limits and collecting and recording all manufacturing data.
The module eliminates the need for operators to have to manually write or use keystrokes to enter data. This not only speeds up production, but it eliminates the potential for recording and transcription errors. Operators only have to touch the computer screen, or scan in bar coded data, to enter information into the system.
Operators are assigned electronic work orders that contain the required formula and Bill Of Materials. Any required processing instructions are also displayed. The system prompts the operators to scan a bar code label on the raw material ingredient container, to verify that the correct ingredient and lot have been selected.
The system prompts the operators to weigh the required quantity. The computer takes weight data directly from the scale and verifies that the required weight is accurate before it will accept and record the weight information. A bar code label, that contains human readable and bar code data, is then printed and applied onto the batched pre-weigh container. After the total batch has been completed the system prints out a batch report sheet. Searches/ queries and custom repots can be compiled from the information collected.
After all the ingredients required for a formula have been weighed, the operators assemble the ingredients onto a skid for shipping to the mixing and blending area. As each container is placed onto the skid the bar code label is scanned to verify that all the ingredients for the order are there. It quickly displays if any ingredients have been missed and it will not allow ingredients from other orders to be assembled. When the assembly is complete the skid is taken to the mixing area.
Operators in this area are mobile, so they use portable computer workstations. The operators are prompted to scan the pre-weighed bar code ingredient container labels as they are added to the mixing tank. The system will only accept the required containers for that order. Additional bulk ingredients are sometimes added at this stage of manufacturing.
When all the required ingredient and containers for the order, have been correctly added to the mixer, the container bar cods become redundant, the system then prints out a new bar code label to identify the combined ingredients that are now in the batch tank.
When the mixing is complete and the product is finished, the system prints a bar code label, to be placed onto a sample container, which is then sent to the Quality Assurance laboratory for testing. Once the laboratory has approved the batch, the product is ready for pack-out.
The finished product in the mixing tank is packed out into various sized containers. These containers are placed onto a scale and after they are filled, the system prints out a bar code label that is placed onto the container.
Once all the containers have been filled and the mixing tank is empty, the system automatically calculates and records the batch yield. If the yield produced is exceeds the preset tolerance, notifications are displayed.
This module contains several other functions that ensure compliance and improve performance and quality. One of them is a scale calibration function that records data on all the scales used in the plant and their required accuracy, testing requirements and inspection frequencies. The system will not allow a scale to be used in manufacturing unless they are meet the required accuracy and have been inspected within the required time period.
Another useful function is called tank management, which allows mixing and processing tanks to be reserved for specific orders. The tanks can also be reserved for cleaning, or maintenance requirements. The system will not allow a tank to be used in production, unless it has been cleaned and released for use. By providing complete electronic records of all the tanks activities, this option eliminates the need for companies to keep paper tank usage records.
[edit] Summary of MES
The MES module eliminates an operator’s ability to make a bad batch caused by using incorrect materials, incorrect lots, incorrect weighing, incorrect recording, incorrect calculations, or incorrect data transcription. These are among the most common cause of manufacturing errors. By eliminating the paperwork and streamlining the manufacturing processes, this module increases production output by 20 to 45 percent.
[edit] Issues with Chemical Batch Manufacturing Today
The majority of companies studied still continue to use manual data collection / entry systems.
Though there are numerous problems associated with manual data entry (inaccurate recording, transcription errors, etc.), one of the largest problems with manual data entry is delay.
Companies that do not have real time data visibility cannot effectively react to a constantly changing business environment.
Valdata’s goal is to supply validated and integrated solutions that provide 99.99% accurate real-time data to employees throughout the organization.
