Jorge Izquierdo, Vice President, Market Development, PMMI, The Association for Packaging and Processing Technologies
Standards play a vital role in the production of solid dosage forms. Compliance with standards results in safer machines and working environments, fulfi lls legal requirements, reduces liability exposure, and protects corporate and brand reputation, according to the Impact of Global and Local Standards on OEMS & Suppliers, a report published by PMMI Business Intelligence, a division of PMMI, The Association for Packaging and Processing Technologies.
To simplify compliance for the production of solid dosage forms and other products, PMMI has released an ANSI-approved overhaul of the American National Standard on the Safety of Packaging and Processing Machinery. Known as ANSI/PMMI B155.1-2023 Safety Requirements for Packaging and Processing Machinery and focused largely on risk assessment, the updated standard introduces critical changes that prioritize user safety and address evolving safety concerns, technological advancements, and changing operational landscapes.
In addition, the scope of the updated standard provides a more precise understanding of its applicability, reduces ambiguity, and simplifies implementation. Finally, a restructured layout streamlines reading for enhanced clarity and ease of reference. A series of annexes offers additional resources like risk assessment for hygienic design and a description of good and bad hygienic design features, a list of packaging and processing machinery hazards, guidelines for the risk assessment process, sample risk assessment documentation, advice for sharing information about residual risk, a sample statement of conformity, general guidelines for operator training, alternate methods for controlling hazardous energy, an outline for information for use/user manual content, risk scoring systems, and layout analysis.
Beyond risk assessment, adherence to ANSI/PMMI B155.1-2023 helps ensure product quality and provides:
- A common ground for best practices and communication with OEMs
- A foundation for in-house safety procedures
- Less chance of schedule- and budget-disrupting surprises during the design process
- A more functional machine
- Greater uniformity across lines, plants, and markets
- Higher ROI.
To revise the ANSI/PMMI B155.1 standard, PMMI convened a panel of industry experts representing machine builders, consumer packaged goods companies, and technology suppliers. “By introducing these comprehensive updates, the ANSI/PMMI B155.1-2023 standard sets a new benchmark for safety in the packaging and processing machinery industry,” notes Tom Egan, Vice President, Industry Services, PMMI. “This revised standard reaffirms the commitment of PMMI to the safety and well-being of industry professionals, ensuring that technological advancements go hand-in-hand with the highest levels of safety.”
John Uber, Head of Product Compliance for Mettler Toledo, a PMMI member company, adds, “Safety is critical to all operators. With an evolving work landscape, having industry standards that are rigorously evaluated on a consistent basis allows us to stay vigilant in mitigating risk.”
The latest version of the ANSI/PMMI B155.1 Safety Requirements for Packaging and Processing Machinery standard aligns with U.S. (ANSI), international (ISO and IEC), and European (EN) standards relating to risk assessment and machinery safety. Suppliers meeting its requirements may simultaneously meet the requirements of ISO 12100 and ANSI B11.0.
In its primary focus, the machinery standard guides packaging and processing machinery suppliers and users through a formal, documented risk assessment process designed to ensure that reasonably foreseeable hazards are identified, and corresponding risks are reduced to an acceptable level. This is accomplished by identifying hazards, assessing initial risk, reducing risk, assessing residual risk, achieving acceptable risk, validating risk reduction measures, and documenting each step. Although risk is primarily associated with safety, it also may impact productivity, equipment, environment, and reputation.
Refined Responsibilities
In other key changes, the ANSI/PMMI B155.1-2023 standard defines responsibilities for all stakeholders, including co-packers and co-manufacturers, and updates legacy machinery requirements.
The revised text explicitly outlines the responsibilities of machinery suppliers, users, modifiers, purchasers of used machinery, and other stakeholders, fostering a safer working environment through increased accountability. According to the standard, machine and component suppliers are primarily responsible for identifying and complying with all relevant standards. Thus, pharmaceutical manufacturers typically require OEMs to supply certifications and declarations confirming all requirements have been met.
One exception is the relatively new concept of machinery-as-a-service, or MaaS, which includes equipment loaned or provided by a third party and located in a user facility, as well as mobile platforms, and robots used for logistics, cleaning, and other tasks. According to the revised standard, the end user and supplier of MaaS shall work together to reduce risks to an acceptable level.
Another exception to the machinery/component supplier(s) assuming responsibility for standards compliance is when the solid dosage manufacturer (end-user), provides equipment or a service for a particular work activity. In that situation, the end user is considered to be the supplier. The revised text also clarifies responsibilities for evaluating existing (legacy) and used machinery for risks to ensure that older equipment is brought in line with the latest safety standards in a practical, cost-effective, and appropriate way.
Other Updates
The updated ANSI/PMMI B155.1-2023 standard also provides expanded information in several areas beyond risk assessment. With the advancement of remote operations, the standard now offers improved information and guidelines for safely operating machinery through remote means and addresses concerns such as cybersecurity.
Revisions also define comprehensive requirements for situations where whole body access is applicable, safeguarding operators from potential hazards such as an equipment restart when someone is dangerously close to the machine’s moving parts.
Other changes include expanded requirements for radiation hazards and associated risk reduction measures, new requirements for heated systems and related equipment for processing of materials, and updated requirements for information for use and manuals including information about any implemented cybersecurity measures.
Background to ANSI/PMMI B155.1-2023
The 2023 edition of ANSI/PMMI B155.1 represents a 51-year evolution since the PMMI membership approved the first version of the standard on Sept. 27, 1972, followed by ANSI approval on Aug. 6, 1973. Since then, the standard has been reviewed and revised with subsequent approvals by the ANSI Board of Standards Review in 1979, 1986, 1994, 2000, 2006, 2011, and 2016. The ANSI/PMMI B155.1-2023 standard is available for purchase through the ANSI webstore.
PMMI Technical Services helps PMMI members and solid dosage manufacturers navigate standards and regulatory requirements and changes and oversees the writing of standards. It also helps train engineers to understand industry requirements and improves industry knowledge of the standards process with resources such as a free, three-module course, Introduction to Standards Development I, II, and III. Finally, it develops tools such as PackSafe® software. Produced with the help of OEMs and design safety engineering, inc., the PackSafe program and its companion, designsafe 9, guide machine builders and manufacturers of solid dosage forms through the risk assessment process.
Manufacturers of solid dosage forms will have an opportunity to learn more about the ANSI/PMMI B155.1-2023 Safety Requirements for Packaging and Processing Machinery standard and see standards-compliant machines at PACK EXPO East (March 18-20, 2024; Pennsylvania Convention Center, Philadelphia). As the most comprehensive packaging and processing show on the East Coast, PACK EXPO East delivers cross-over solutions along with the time to dive into detail with more than 400 key suppliers. With dozens of free educational sessions presented on the show floor, makers of solid dosage forms will have the opportunity to hear from experts, learn about new applications, and gain ideas to put into action. At PACK EXPO East, attendees will see a wide array of equipment, containers, materials, and components for solid dosage production as well as warehousing and automation solutions under one roof. Located within a few hours of much of the East Coast, this show is convenient and affordable for entire teams to attend. For more information and to register for PACK EXPO East, visit packexpoeast.com.
Other Standards May Apply
Although risk assessment and risk reduction standards such as the ANSI/PMMI B155.1-2023 Safety Requirements for Packaging and Processing Machinery standard define foundational requirements for packaging and processing machines, it’s likely additional standards apply to any processing and packaging line. These other standards may relate to mechanical safety, electrical safety, specific machine categories, hygienic design, specific product categories, hazardous environments, processing, and automation. This is especially true in the pharmaceutical industry, which is subject to a stringent regulatory environment and where product safety and efficacy are primary objectives.
Determining which standards apply to solid dosage production depends on machine location and attributes plus in-house requirements. To ensure no details are overlooked, PMMI’s Impact of Global and Local Standards on OEMS & Suppliers report recommends solid dosage manufacturers gain a working knowledge of the standards in effect where the machine will be installed. For example, machines destined for the EU must conform to the applicable EU directives, particularly CE Marking requirements, which are primarily governed by the Machinery Directive, the Low Voltage Directive, and the Electromagnetic Compatibility Directive. European Standards, or European Norms, which carry an EN designation, also may apply. In addition, suppliers and end users must be cognizant of national and local requirements like Cook County, Illinois, (Chicago), which has stringent electrical requirements.