새로운 프로그램을 위한 혁신적이며, 협업이 가능한 동기화된 프로그램 관리
항공 우주 및 방위
새로운 프로그램을 위한 혁신적이며, 협업이 가능한 동기화된 프로그램 관리산업 자세히 보기
자동차 및 운송
Integration of mechanical, software and electronic systems technologies for vehicle systems산업 자세히 보기
소비재 및 소매업
통합된 포뮬레이션, 패키징 및 제조 프로세스의 효율적인 관리를 통한 제품 혁신산업 자세히 보기
전자 기기 및 반도체
신제품 개발 시 데이터를 활용하여 품질과 수익성을 개선하고 시장 출시 기간을 단축하며 비용 절감산업 자세히 보기
에너지 및 공공 시설
Supply chain collaboration in design, construction, maintenance and retirement of mission-critical assets산업 자세히 보기
Construction, mining, and agricultural heavy equipment manufacturers striving for superior performanceExplore Industry
산업용 기계 및 중장비
Integration of manufacturing process planning with design and engineering for today’s machine complexity산업 자세히 보기
Insurance & Financial
Visibility, compliance and accountability for insurance and financial industriesExplore Industry
조선 및 해양
미래형 선박(future fleet) 개발 비용의 지속적인 절감을 위한 조선분야의 혁신산업 자세히 보기
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
의료 기기 및 제약
시장 요구사항의 충족과 비용 절감을 위해 디지털화를 통한 "개인 맞춤형 제품 혁신"산업 살펴보기
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