PMO compliance using thermal processing solutions
Compliance with the US standards found in the Pasteurized Milk Ordinance and/or per 21 CFR, part 113 are paramount to ensure safety within the Food & Beverage industry
The Pasteurized Milk Ordinance (PMO) ensures Grade 'A' milk and dairy products from the United States are among the safest in the world. To ensure that level of protection, numerous critical control points are used throughout these systems. Endress+Hauser provides a comprehensive range of hygienic instrumentation for the Food & Beverage industry.
Benefits
- Compliance to regulations
- Product safety
- Reliability of operations
Typical applications:
- Continuous pasteurization in HTST, UHT, ESL and aseptic
- Juice pasteurization
- Egg pasteurization
- Cold product recording
- Product tank/silo temperature and level - such as raw milk or aseptic tanks
- Clean-in-Place (CIP) and Clean-out-of-Place (COP) records
- Retort, low acid foods per 21 CFR part 113
- General process recording and monitoring
A simplified system for compliance
Endress+Hauser offers a broad range of products and solutions to ensure compliance with applicable food safety standards and requirements such as:
- 2023 revision of Pasteurized Milk Ordinance for HTST, UHT or aseptic processing systems (M-b-379, 380, 381 and 385)
- 21 CFR Part 11 for electronic record keeping
- 21 CFR Part 113 for low-acid food production
- Hygienic sensors that meet 3-A sanitary standards and are certified according to test procedures of EHEDG
Controller (STLR/SFLR) Safety Thermal Limit (flow) Recorder
Memograph M RSG45 digital data manager hardware and Field Data Manager (FDM) software by Endress+Hauser enables reliable, secure measured data recording, electronic record management, archiving and transmission as specified in the FDA 21 CFR Part 11, compliance with PMO (M-b-385) and process authority requirements.
Recorded data
Recorded data is stored on Memograph M RSG45 in 256 mb RAM memory and backed up on internal 1 gb SD memory which holds approximately 24 weeks of data when used as STLR/SFLR with a one-second recording interval. The FDM reporting software is installed on a local SQL server and connected to Memograph M RSG45 via LAN (EtherNet TCP/IP) for instant access to current and recorded data.
Annotations
Operators can enter annotations directly on the recorder or local server workstation. Records and annotations are available directly at Memograph M RSG45 for review and approval. The FDM provides a platform for supervisors, regulatory, quality, etc., to access records and annotations as well as workflow to approve and save records securely on company servers. Printing of records is available.
- Secure data storage and access on a local server
- Secure and tamper-proof database per 21 CFR part 11 and encryption and CRC (cyclic redundancy check)
- FDM supports unlimited number of Memograph M RSG45 DDMs and is a one-time installation with no recurring licensing fees
- Multi-level user access with up to five concurrent users as standard (more on request)
Electromagnetic flow
Proline Promag H 300 and Proline Promag H 500
Proline Promag H 100, 300 and 500 offer:
- PMO compliance for Meter Based Timing (M-b-379, M-b-380 and M-b-381)
- Compact and remote transmitter options
- Easy standardization - standard meter can be applied for regulatory applications by applying kit-accommodating application of regulatory wire seal (Endress+Hauser part # DTSP-AT1XZ8 - TSP 71417487)
Temperature
iTHERM CompactLine TM311 temperature sensor
- Highest level of vibration, water ingress and measurement speed utilizing tip sense
- Innovative use industry of standard M-12 connection with tamper-proof M-12 sealing for regulatory compliance
- Suitable for HTST, UHT and aseptic ranges
Pressure transmitters across regeneration stage
Cerabar PMP43 hygienic pressure transmitter
- Compact housing
- Innovative use industry of standard M-12 connection with tamper-proof M-12 sealing for regulatory compliance
- General use in HTST, UHT and aseptic systems
- Specialized configurations available - PMO compliant for heat exchanger differential pressure (with seal) and aseptic systems for steam injector
RFID reader for Memograph M RSG45 and FDM login using employee RFID badge; Endress+Hauser collaborates with rf IDEAS, part # RDR-805W1BKU and Panel Mount IP67 Kit: KT-IP67
Additional documents
Click to download the following Memograph M RSG45 Pasteurized Milk Ordinance documents:
- Memograph M RSG45 manual and M-b-385
- Regulatory systems overview
- How to enter annotations
- 7-day installation report
- Operator user guide
- Compliance solutions
- Appendix I
Click to download the following Field Data Manager documents:
Where can I find the Pasteurized Milk Ordinance guidelines?
The official Pasteurized Milk Ordinance (PMO) guidelines are published by the U.S. Food and Drug Administration (FDA) as part of the Grade “A” Milk Safety Program. The most current revision — including sections relevant to HTST, UHT, ESL and aseptic processing systems. This is also where you can find the relevant memorandums for Endress+Hauser products (M‑b‑379, M‑b‑380, M‑b‑381 and M‑b‑385).
What are key requirements of the Pasteurized Milk Ordinance?
The Pasteurized Milk Ordinance (PMO) requires strict control of pasteurization time, temperature and flow, along with verified differential pressure, compliant forward/divert logic and secure, tamper‑proof electronic records to ensure safe Grade “A” dairy processing.
What violations are related to pasteurized milk regulations?
Common violations typically stem from failures at PMO legal control points. Frequent issues include improper flow rates that let product move through the holding tube too quickly, inadequate pasteurization temperature and insufficient differential pressure across the heat exchanger, which risks raw–pasteurized cross contamination. Each of these violations compromises food safety.
What are the best providers for Food & Beverage solutions?
One of the leading technology providers is Endress+Hauser, providing measurement instrumentation and digital data management required for HTST, UHT, ESL and aseptic systems. Endress+Hauser offers complete instrumentation for flow, temperature, pressure and digital data management, along with compliance‑focused tools supporting PMO requirements and 21 CFR Part 11 electronic recordkeeping. Our Food & Beverage portfolio is designed specifically to enhance product safety, reliability and regulatory compliance.
What are the latest innovations in Food & Beverage industry?
The latest innovations center on Endress+Hauser's Memograph M RSG45, which now serves as a fully digital, compliance‑ready data manager for food and beverage processing. It supports up to 20 universal inputs, delivers secure electronic records per 21 CFR Part 11 and enables automated PMO‑compliant recording and control for HTST, UHT and aseptic systems. It also integrates seamlessly with Field Data Manager (FDM) for instant audit trails, annotations and multi‑user review.
