Environmental Room Conditions Monitoring System

An automated monitoring system was designed and executed to monitor manufacturing room’s environmental conditions (temperature, humidity and differential pressure) to comply with European Pharmaceuticals regulations. System consists on the development of a Control Logix PAC application and a Web Report Application that monitor rooms environmental conditions and alarms operators before regulatory time period is exceeded. Continuous historical data is collected in order to provide room conditions reports through a webpage.

PK Blender Automation

Manual controlled PK Blender was designed and programmed to execute automatic batch sequence and reports. Design contemplates the programming of a Control Logix PAC application and an iFix Human Machine Interface (HMI). System is fully compliance with 21 CFR Part 11 and includes electronic signatures for different processes. Batch Data Collection and Report system was developed in order to storage batch data, alarms and events on a SQL Server. Crystal Report application was used to be integrated with the HMI in order to facilitate printing and view of Batch Data and Alarm and Events Reports.

Shipper Label Database Repository System

It was requested to us to design a shipper label repository database to access approved shipper labels arts on different packaging lines End of Line Systems. System consists of a SQL Database Server and a Web Application connected to the Manufacturing Network. When shipper labels art is prepared, designer uploads it from anywhere in the plant or out plant site to the SQL Database using the Web Application. System is fully 21 CFR Part 11 compliance and use electronic signature to shipper labels arts approval process.

Shipper Label Print & Inspection System

Using the Shipper Label Database Repository System, our client request us to print and inspect shipper labels on packaging lines. System design consisted on create an HMI that controls Print & Apply machines and shipper labels inspection using Cognex Vision System, and integrate it to the Shipper Label Database. As a result, no shipper labels have to be printed and inspected outside the packaging lines which made the packaging process more efficient and reduce operational costs associated.

Label Inspection and RFID Integration System

As part of the new serialization requirements for pharmaceuticals, our client decides to integrate our existing Shipper Label Print & Inspection System with a RFID System, Casepacker and Palletizer machines. Our scope as part of the design team was to select the RFID devices to use (readers, antennas, etc.), integrate serialize shipper labels print action and inspection with the RFD System, and integrate . inspection results with Casepacker and Palletizer machines in order to accept or reject shipper.

Data Historian System

Once an Automation Network is in place, next step to collect the production floor data is to configure a Data Historian System. This data will be used to provide accurate and better manufacturing and production decisions when needed. Also, it can be used to provide information to maintenance personal and to provide the necessary data for product batch performance and investigation. We have experience working with different historian vendors, and we can provide you the best solution that fit your needs.

Cleaning Data Logger System

Cleaning Data Logger is an automated system used on pharmaceuticals washrooms to create accurate cleaning reports of manual cleaning pieces. System includes a MicroLogix PLC and a Human Machine Interface (HMI) where operator is able to control, monitor and create Cleaning Recipes. Cleaning Batch Data is loaded in a SQL Server where reports could be obtained. System is fully 21 CFR Part 11 compliance and use electronic signature where required.

Automation Network Design and Configuration

In order to provide manufacturing processes data to a higher manufacturing level is necessary to create an Automation Network. We have experience creating networks of DH+, RS232, Ethernet, ContolNet, DeviceNet, among others. Once computers and automation devices are connected together we are able to create Central Historical Data Collector System.

Control System Retrofit

Moriah Engineering Solutions, Inc. has worked on multiples Control System Retrofit including Aqueous Coating System, Vector Coater System, Dryers, Bin Tumblers, Drilling Laser Machines, Packaging Machines, Blender and Granulation System, among others Pharmaceutical Processes Equipment.

Bin Blending

A retrofit design and implementation was requested for a Bin Blender Control System which consisted on the development and configuration of an HMI and PLC control applications. System was designed with a recipe management integrated to SQL Database, Audit Trail, Electronic Signature, among other futures. ControlLogix PAC application was designed to control the manufacturing process and safety issues.

Batch System Modifications

New equipments and process improvements were done to a PK Blender Control System. Modifications to the Batch System were necessaries to implement new add-ons. Project had an implementation time concern issue but be part of the project design team was our key to made a successfully implementation. Our scope was oriented to the creation of new batch phases, configuration and programming, integration with SQL Database, ControlLogix PAC programming, creation of new recipes on Batch System, among other tasks. Product manufacturing and delivering was successfully due to the on time implementation of this project.

Computer System Validation

Our vast experience on Computer System Validation (CSV) activities makes us a successfully team to generate and execute CSV protocol tests. Experience include generation of User Requirements Specifications, Functional and Design Specification documents, Protocol Tests generation and execution, CSV Close-out documents, Computer System Assessments, among other CSV related tasks. Our experiences give us the ability to generate and execute on time CSV documents and tests in order to minimize project time and costs associated.