At BMRG we value the importance of fostering continuous learning and collaboration in the field of biopharma manufacturing maintenance and emergency recovery solutions. We are active members of many leading industry associations such as ASTM, IEST, ISPE, and are certified by IICRC in several key areas. Our solutions delivery partners likewise have a wide range of industry affiliations and certifications and are committed to ongoing training in the absolute latest recovery and restoration standards.
We count on our affiliations and the resources below (and beyond) to stay ahead of industry trends, influence standards development where possible, and deliver solutions that meet the highest levels of quality, safety, and efficiency for our biopharma manufacturing clients.
Biopharma
ASTM
American Society for Testing and Materials International
For over 125 years, ASTM International has been one of the world’s leading scientific standards organizations. The Society currently publishes over 70 peer reviewed biopharmaceutical standards or scientific papers which can be found by clicking on the ASTM logo above.
At BMRG, Reid Saleeby is an ASTM member. We focus our attention on their published standards such as:
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Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control (Designation E2575)
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Standard Guide for Evaluation of Cleanroom Disinfectants (Designation E2614)
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Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation (Designation E3106)
IEST
Institute of Environmental Sciences and Technology
ISPE is the global industry leader in connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence, and regulatory insights to enhance industry efforts to develop, manufacture and reliably deliver quality medicines to patients.
At BMRG, Reid Saleeby is an IEST member. We focus our attention on their published guides such as:
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Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
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Good Practice Guide: Maintenance (Second Edition)
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Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls
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ISO 14644 Series Cleanroom Standards
ISPE
The International Society for Pharmaceutical Engineering
For over 125 years, ASTM International has been one of the world’s leading scientific standards organizations. The Society currently publishes over 70 peer reviewed biopharmaceutical standards or scientific papers which can be found by clicking on the ASTM logo above.
At BMRG, Reid Saleeby is an ISPE member. We focus our attention on their published standards such as:
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Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control (Designation E2575)
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Standard Guide for Evaluation of Cleanroom Disinfectants (Designation E2614)
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Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation (Designation E3106)
FDA
Food and Drug Administration
FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its current Good Manufacturing Practice (CGMP) regulations. The cGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.
At BMRG, we focus our attention and training on the following biopharma Codes of Federal Regulations (CFRs):
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Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs (21 CFR Part 210)
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Current Good Manufacturing Practice for Finished Pharmaceuticals (21 CFR Part 211)
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Biological Products: General (21 CFR Part 600)
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For FDA approval to market a new drug (21 CFR Part 314)
Maintenance & Recovery
IICRC
Institute of Inspection Cleaning and Restoration Certification
Since its founding in 1972, the IICRC has evolved into a global organization with more than 49,000 active Certified Technicians and more than 6,500 Certified Firms around the world with a mission to establish and advance globally recognized standards, credentials, and certifications for the inspection, cleaning, and restoration industries.
At BMRG, John Powers is certified in several IICRC / ANSI areas and we focus on many of their standards.
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Standard for Professional Cleaning, Maintenance, and Restoration of the Commercial Built Environment (First Edition)
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Standard for Professional Remediation of Precursors, Drug Residues, and Associated Chemical Waste
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Standard for Assessing HVAC Systems Following a Water, Fire, or Mold Damage Event (First Edition)
NADCA
National Air Duct Cleaners Association
NADCA supports member success with standards, education, certification, marketing, and advocacy to promote ethics and the highest quality services in HVAC inspection, cleaning, and restoration.
At BMRG, we rely upon the NADCA Standard (2021 Edition) for performing the assessment, cleaning, and restoration (ACR) of HVAC systems, which includes (but is not limited to), the following topics:
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Inspections
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Work Plans
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Engineering Controls for HVAC Cleaning and Restoration Projects
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Cleaning and Restoration Procedures
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Cleanliness Verification and Documentation
ASHRAE
American Society of Heating, Refrigerating and Air-Conditioning Engineers
ASHRAE is an international society of heating, refrigerating and air-conditioning professional engineers. Founded in 1894, ASHRAE is dedicated to advancing human well-being through sustainable technology for the built environment.
At BMRG, we focus our attention on their publications such as:
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Method of Testing General Ventilation Air-Cleaning Devices for Removal Efficiency by Particle Size (Standard 52.2-2017)
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Standard Practice for Inspection and Maintenance of Commercial Building HVAC Systems (Standard 180-2018)
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Resiliency in the Built Environment (Position Document, 2022)