Innovation and collaborative, synchronized program management for new programs
Aerospace & Defense
Innovation and collaborative, synchronized program management for new programsExplore Industry
Automotive & Transportation
Integration of mechanical, software and electronic systems technologies for vehicle systemsExplore Industry
Produkty konsumenckie i handel detaliczny
Innowacyjność produktów poprzez efektywne zarządzanie zintegrowanymi recepturami, opakowaniami i procesami produkcyjnymiDowiedz się więcej o branży
Electronics & Semiconductors
New product development leverages data to improve quality and profitability and reduce time-to-market and costsExplore Industry
Energy & Utilities
Supply chain collaboration in design, construction, maintenance and retirement of mission-critical assetsExplore Industry
Construction, mining, and agricultural heavy equipment manufacturers striving for superior performanceExplore Industry
Integration of manufacturing process planning with design and engineering for today’s machine complexityExplore Industry
Insurance & Financial
Visibility, compliance and accountability for insurance and financial industriesExplore Industry
Shipbuilding innovation to sustainably reduce the cost of developing future fleetsExplore Industry
Media & Telecommunications
Siemens PLM Software, a leader in media and telecommunications software, delivers digital solutions for cutting-edge technology supporting complex products in a rapidly changing market.Explore Industry
Medical Devices & Pharmaceuticals
“Personalized product innovation” through digitalization to meet market demands and reduce costsExplore Industry
Faster time to market, fewer errors for Software DevelopmentExplore Industry
Small & Medium Business
Remove barriers and grow while maintaining your bottom line. We’re democratizing the most robust digital twins for your small and medium businesses.Explore Industry
Siemens Digital Industries Software Master batch record (MBR)
A master batch record (MBR) contains the instructions, recipe or formula, and specific manufacturing process for a particular product. Also known as a master production record (MPR) or master manufacturing formula (MMF), an MBR is required in some industries – most notably, pharmaceuticals – by regulatory bodies or industry advisory groups. The U.S. Food and Drug Administration (FDA), for example, requires manufacturers that fall under its jurisdiction to create and maintain an MBR for each product formulation/recipe and batch size.
Master batch records are intended to ensure that manufacturers use the right ingredients and the right processes in the right sequence to make the product as it is designed. The key result is that product characteristics and performance are the same from batch to batch.
Historically, the master batch record was generated and maintained on paper. Numerous benefits are gained by using MBR software to create and manage an electronic master batch record: accessibility, easier version control, opportunities to enforce compliance, fewer errors, and greater efficiency, to name a few. Master batch record software is part of a manufacturing execution system (MES) and is seamlessly integrated with MES workflow management. This integration streamlines batch production operations.
The master batch record is created by the appropriate technical staff. MBR software enables these individuals to efficiently design, execute, review and release the master batch record for each product and batch size.
As the name suggests, the master batch record (or master production record or master manufacturing formula) lays out the planned manufacture of a product. For each batch that follows the MBR, an electronic batch record (eBR) is produced. What the MBR lays out is what is expected to happen; the eBR documents what actually happened in the production of an individual batch – what material lot, specific equipment, and operators were involved; duration of each step; sample and test results; and so on.
To ensure sufficient information is available to maintain product consistency from batch to batch, the master batch record should include the following pieces of information:
Product name and reference code (if one exists)
Patent number (if one exists)
Product properties and characteristics
Product formula or composition
Bill of materials
Bill of process
Expected yield after each process step
Acceptable machinery to be used and its location
Work instructions for each station/stage of production
Quality procedures, including sampling, testing, and acceptable results
Required packaging and storage conditions
Special safety requirements
MBR software provides electronic management of master batch records. It expedites the design, execution, review and release of match batch records and connects them electronically to each eBR.
Flexibility in the MBR design process
Faster information exchange and retrieval
Fewer human errors