It's so easy: PMO compliant Process Control with ditigal or chart recorders
The Grade “A” Pasteurized Milk Ordinance (Grade “A” PMO) is the sanitary regulation for milk and milk products. PPR, the new generation Paperless Process Recorder with Legendary™ software, creates PMO-compliant digital audit-ready records ...
How process recorders can help you optimize processes and assuring quality
The Grade “A” Pasteurized Milk Ordinance (Grade “A” PMO) is the sanitary regulation for milk and milk products which is recognized by all Public Health Regulatory Agencies at local, state and federal levels (USPHS, FDA) and adopted by the entire dairy industry. It has been a gold standard even for applicable food and beverage industries..
PPR, the new generation Paperless Process Recorder, offers a secure digital PMO-compliant solution with significant cost-saving potential. Coupled with Legendary™, this combination of hardware and software creates digital audit-ready records for applications in dairy, food, and beverage industries.
In April 2023, the M-b-383 (Memorandum-b) was issued by the FDA, making PPR the first digital process Recorder for PMO applications with M-b.
With the PPR and Legendary™ solution, Anderson-Negele helps manufacturers accelerate their digital transformation. By increasing the reliability of recording process through reduction of hardware dependencies, these elements increase the flexibility of the review and approval process while providing cloud software to do so remotely. The PPR hardware and Legendary™ cloud solution have been designed to ensure data quality and integrity that meets the high standards set by regulatory bodies like PMO and FDA 21 CFR 11. LegendaryTM provides simple and intuitive workflows for review, approval, archiving and retrieval of digital charts which improves efficiency of operators, supervisors, and quality team.
For over 30 years Anderson has been the leading developer and supplier of systems for process monitoring for every specific pasteurization application outlined in the PMO. Besides the new paperless recorder technology, the product range complies several types of classic drag pen recorders with circular charts. With up to four recording inputs with optional PID controllers the types AJ-3000 and AJ-9000 provide a comprehensive range of individual configurations to perfectly match the processes.
Our VAT system is supplied on the majority of batch processors used to pasteurize dairy products like ice cream mix, specialty cheeses and yogurts, and seasonal products such as egg nog.
For HTST and other continuous pasteurizers, customers rely on our failsafe controls including the DART as their reference thermometer, GB Differential Pressure Switch for regenerator protection, and AV9900 for final control of temperature and flowrate to ensure compliance and a safe product.
It‘s new and so easy: Digital Process Control with PMO compliant PPR and LegendaryTM
PPR (Paperless Process Recorder) is a digital chart recorder system that can be used in pasteurization, CIP, COP, raw silo monitoring and in general any application that requires monitoring of process parameters like temperature, flow, pressure, level, conductivity, turbidity etc.
LegendaryTMis a cloud-based software that securely stores records from all PPRs of your plant in a single location. It allows you to conveniently access, review and approve those records remotely from your office desk or home office and through a secured online access using any web-enabled device all while meeting PMO compliance.
The combination of PPR hardware and LegendaryTM Software forms a next generation paperless recorder system. This PMO compliant Digital Process Monitoring technology makes your digital transformation easy.
It’ so easy to go digital and remain PMO compliant
You can easily connect all existing sensors of your application to the PPR unit. Operators can check all trendlines, add annotations, and approve them directly on PPR’s touch screen display. You can also add annotations and approve records remotely from LegendaryTM cloud software all while remaining PMO compliant.
Memorandum-b: The M-b is a letter which is issued by the FDA to show that a particular device/system has been found to be compliant with a section or application within the PMO. Before the FDA will issue a M-b an in-depth technical product review by one of the US Regional Dairy Equipment Review Committees is required. A Memorandum-b gives state dairy regulators confidence that the product meets all PMO requirements and reduces the complexity and risk of each state approving a new piece of technology following their own review. In April 2023, the FDA has issued a M-b (M-b-383) for an electronic recorder/controller to be used in pasteurization applications and Anderson-Negele’s PPR thus is the first digital system to achieve this.
It’ so easy to review and approve records
The classic chart recorders are paper based and heavily dependent on manual processes – retrieving, installing, and annotating on charts, as well as collecting, reviewing, approving, and storing charts. These activities can be cumbersome and prone to confusion and error. The PPR and Legendary™ solution streamlines these workflows by removing non-value-add steps and increasing efficiency. The touchscreen display of the PPR eliminates the need for paper charts and optimizes the annotation process. The records created by the PPR are stored locally AND uploaded and stored securely in the Legendary™ software. Chart records can be reviewed, tracked, and audited by supervisors, quality teams and inspectors locally or via any web device remotely through a secured internet access. Approved records are marked ready for audit and are stored securely for easy retrieval anytime in future. With LegendaryTM QA can review and approve records from all PPRs of your plant remotely and have them Ready-for-Audit by state inspector. That reduces handling time and human error and makes this software an indispensable tool for quality management
It’ so easy to store and retrieve records
LegendaryTM securely saves all historical records and makes them available at the fingertips of the authorized users. No need to worry about charts getting wet, torn, damaged or lost while handling or storing.
It’ so easy to accelerate digital transformation
The PPR and Legendary™ can do more than just legal data logging. Through data evaluation, the system has potential for process optimization at the plant. Process flows can be more easily controlled, and potential errors in the processes can be detected and eliminated.
It’ so easy to avoid consumables cost
Current paper-based recording solutions utilize paper charts, pens and ink cartridges that have multiple layers of cost. These include the actual cost of the consumables as well as cost to procure, store and discard them. These paper-based recorders can also lead to additional complications like using the wrong chart, pen, or ink cartridge, damaged/lost charts, and illegible charts when getting wet or when the ink runs out without noticing. All of which result in increased expense or missing data. With the digital solution, PPR and Legendary™ eliminates the need for these costly consumables and minimizes the opportunity for human errors.
It’ so easy to avoid unplanned downtimes
Current paper-based process recorders use several moving mechanical components for recording and printing. While the frequency of use might delay it, all these recorders experience mechanical failures with pen-arms, motors, boards, and other components that can cost manufacturing plants thousands of dollars a year. The new PPR does not use any moving mechanical parts, which not only reduces overall cost of replacement parts, but also drastically reduces the need for maintenance support. As the digital PPR technology works without pen arms, motors and other moving parts, plant downtime due to mechanical failures and MRO events are a thing of the past.
It’ so easy to comply with FDA 21 CFR regulations for electronic records and signatures
In Title 21 of the Code of Federal Regulations, the Food and Drug Administration (FDA) regulates, among others, the requirements for the manufacture of foods, drugs, and cosmetics. Part 11 defines the exact regulations for electronic records and electronic signatures and applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations (FDA website. The PPR and LegendaryTM have been designed to meet all technical and system requirements of Part 11 from the beginning.
The digital data management with PPR and LegendaryTM makes process recording easier, but for internal documentation and workflows the specific regulations have to be known and respected. In addition to prior regulatory charting requirements, Part 11 becomes applicable in certain PPR & Legendary applications due to the electronic records created by PPR and the signatures that are generated though PPR and Legendary™.
For users of the PPR and LegendaryTM Solution Anderson-Negele has created a special application guide. This document provides guidance how the system itself complies with the regulations, and how the client can easily validate compliance to FDA 21 CFR Part 11 in their recording application. It provides assistance to the adaptation of internal processes and security in dealing with the FDA Regulations for all people in charge of the processes or involved in their execution.
It’ so easy to get support
PPR and LegendaryTM is the next generation process recording technology. It is much more than just recording digital trendlines for temperature, pressure, flow, conductivity or other process parameters in a data logger, a graphic recorder, or a historian solution. By providing PMO compliant workflows to create digital charts embedded with digital annotations and providing intuitive process to review and approve records, PPR and Legendary™ helps your plant and quality team get audit ready for state inspection and internal or third-party audits. We understand that a new technology can sometimes create uncertainty, resistance from staff, and raise questions. We are here to assist you in each step of decision making and system introduction, and, once installed, to make sure your PPR and LegendaryTM run smoothly to provide you maximum benefits.