At BEPC, our mission is to provide our medical device, pharmaceutical, and biotech clients with innovative consulting services focused on continuous improvement through the implementation of the latest industry methodologies at an exceptional value.
Commissioning and Qualification of Manufacturing Cleanrooms
BEPC has extensive experience in the systematic process of commissioning and qualifying cleanrooms and or start-ups. Such experience has included pre-commissioning, and commissioning relating to the quality assurance of a fabrication & installation process for: facilities, utilities, and equipment. Our commissioning and qualification experience has demonstrated adherence and conformance in regards to exclusive User Requirements and Design Specifications per project requirements.
BEPC received the opportunity of participating in a complex qualification project involving two cleanrooms that comprised a total area of 162,000 square feet for a top Fortune 100 Life Science Company. The project consisted of implementing and integrating two systems-Environmental Monitoring System, and a Building Management System. The blending of these two systems enabled the control and monitoring of: airborne particulates, temperature, pressure, and humidity data, on a continuous basis (controlling & monitoring was done minute after minute). In part of the commissioning and qualification efforts, BEPC successfully commissioned all the ancillary systems for the startup building, as well as participating in identifying the software development team. This allowed and ensured for all User Requirements Specifications to be met in regards to the integration of these two systems. BEPC was also able to utilize a Computer System Validation Methodology that qualified all computerized systems during the commissioning and qualification of the two cleanrooms. This system followed all instructed, customer specified procedures, industry best practices, and FDA regulations. BEPC also served as the exclusive, temporary staffing agency for the recruitment of: microbiology scientists, quality assurance engineers, and project management professionals. These temporary professionals participated in the development, execution, and data testing and reporting activities, that were exclusively related to the commissioning and qualification of these two cleanrooms.
Technology Transfer of Products and Processes from the U.S, Europe, Costa Rica, Australia, and Puerto Rico to Mexico for a range of life science industry customers
BEPC has a wealth of experience with product, process, and equipment transfers domestically and internationally. BEPC engineering experts have led, executed, and utilized the latest technology transfers while implementing new technology involving major projects. Because of such successful transfers by BEPC professionals, such transfers have allowed start up manufacturing activities to meet all customer schedules in which has enabled the continuous focus on Quality Management System Compliance.
Supplier Quality Audits (DESKTOP/ON-SITE) for companies involve: supplying raw material components for the manufacture of medical device products throughout the United States, Mexico, Brazil, and Israel
BEPC’s Supplier Audit Team includes Audit Coordination, Certified Quality Auditors, and Certified Biomedical Auditors that specialize in customer suppliers who provide services such as: software, components, sub-components, sub-assemblies, transportation, design houses, and raw material.
The audits scope include and are not limited to:
- Quality Management System
- Control of Records
- Management Review
- Pest Control
- Control of Documents
- Change Management
- Preventive Maintenance
- Supplier Evaluation and Approval
BEPC Supplier Auditing Team, has been recognized by its customers as a company who utilizes current industry best practices when it comes to the reporting of audit status (financially and operationally).
Validation (IQ/OQ/PQ) of Manufacturing Processes
BEPC Consultant professionals include but are not limited to: regulatory specialists 510k submissions, combined product specialists CFR 210 and 211, microbiology scientists, quality assurance engineering, and validation engineering. These consulting professionals have led and executed activities regarding different functions which have supported BEPC’s customers and their core initiatives. BEPC’s Subject Matter Experts provide timely and appropriate instruction when it comes to manufacturing process validations, focused on Six Sigma and Lean methodologies. In the last several years, BEPC has successfully supported several manufacturing process validations which included a wide range of products: suture-needle assembly, cardio vascular needle manufacturing, suture vascular closure devices, three-piece Modular, Abdominal Aortic Aneurism Stent-Graft System, dilatation catheters for femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, as well as a catheter sheath introducer used for both diagnostic, and interventional procedures in cardiology and radiology.
Quality assurance and engineering personnel leading and supporting quality system remediation activities at several medical device companies that are located domestically and internationally-e.g. Mexico
In 2014-15, as part of a plant-wide, quality systems’ remediation effort at a major medical device facility in Utah, several BEPC consultants were hired to address quality system gaps in the areas of supplier quality, CAPA, NCR, IQ/OQ/PQ validations, complaints and process engineering. Some of the BEPC Consultants were recognized for their efforts/results and given additional leadership responsibilities while working at the Site. The work performed by BEPC Consultants and others, lead to effective corrective actions resulting in an improved compliance position for the company.
Sterilization Engineering Services provided to medical device companies throughout the United States and internationally-e.g. Mexico
From 2011 – 2013, BEPC Engineers performed primary packaging and sterilization development studies and validations of medical devices, that were transferred from site locations in Europe to a Mexico/US split-flow assembly/packaging/sterilization manufacturing process. This effort resulted in significant cost savings for this US based Fortune 50 international Medical Device company.
Packaging Engineering improvement and validation engineering services to medical device companies located throughout the United States and internationally-e.g. Mexico
For the last several years, BEPC Packaging Engineers have been hired at several Fortune 500 medical device companies. Locations include: Bay Area of California, Southern Florida, Texas, Utah and Mexico. The packaging improvement work included new product introductions, CAPA remediation, next generation packaging improvements, as well as vision and automated systems for packaging. BEPC Packaging Engineers have the experience and training needed with the most popular Industrial Vision Systems and Automated equipment to ensure the flawless inspection to protect customers against potential recalls caused by defective products and packaging.
Analytical Statistics’ Expertise in Validation and process improvements and technical training
BEPC has long term engineer/analysts (considered SME’s) that are frequently assigned opportunities to assist with complex quality/engineering issues. Among the more complex assignments, BEPC statistical analysts have been involved in the commissioning & qualification of clean rooms; re-validations of equipment/processes; establishing compliant/robust variable and attribute sampling plans; and Certified Master Black Belts have provided training in statistics and statistical analysis in a regulated environment.
Project Management Expertise covering a wide range of complex life science projects-globally
BEPC Project Managers (several PMP certified) are currently working on major projects in Northern Florida, Southern Florida, Utah and Juarez, Mexico. These complex projects, often multi-site/multi-country, include clean room commissioning & validation, new product extensions, multi-country equipment & process transfers, and new medical device labeling systems.
BEPC Incorporated also offers Expert Training and Assessments:
- Six Sigma and Lean Thinking Training/Consulting
- Statistical Engineering I & II Training
- Design of Experiments Training
- Accelerated Life Testing Training
- Statistical GAP Analysis Assessments