A planned shutdown is ideal and should be carefully planned months in advance. A well prepared shutdown gives operators the opportunity to repair and prevent issues which will help to avoid unplanned shutdowns, outages or worker injuries. Planned shutdowns should be viewed as an investment, not an expense. AMA has been involved in helping clients …
Ensuring Shutdown Success: Tips to Maximize Planned Maintenance Read More »
Novo Nordisk developed this facility to produce insulin injecting pens. The magnitude of the validation scope required a strategy to streamline and digitize the administrative processes and documentation. AMA developed and distributed software (utilizing Excel and Access) designed to merge, organize and categorize published engineering document databases and site quality walkdown punchlisting with various mechanical …
Project Spotlight: Novo Nordisk DAPI-US, Clayton, NC Read More »
We’re celebrating the 15 year anniversary of Zach Yauch working for AMA Consultants this year! Zach joined AMA in 2006 and has an extensive background in pharmaceutical and semiconductor high purity process systems testing and validation, cleanroom performance testing, and nuclear fuel canister manufacturing, testing and QA. With SNT Certifications in leak testing and visual inspections and over 15,000 …
The technological advancements for the high-tech industry over the last 30 years have been astounding and we have seen growth not experienced by other industries. The semiconductor and bio-pharmaceutical advancement in technology have presented challenges, not just technical, but logistics and installation. Material and installation inspection requirements have become more stringent as specifications and tolerances …
AMA Consultants is continually seeking to innovate, approaching each client and project with open minds to deliver our services in ways that provide additional value. Specifications and regulations are always followed rigorously to ensure compliant QA/QC programs, however organizational structure, means and methods, communication and coordination could contain opportunities to make a measurable difference in cost …
Pharmaceutical and medical device manufacturing facilities among the most complex industrial buildings, creating some of our most personal, sensitive and important products. Each building contains numerous pieces of integrated equipment, highly controlled support and utility systems, and regulated monitoring and documentation requirements. Add in that there are typically numerous environmental testing contractors who each produce …
Balancing Multiple Teams, Systems, and Data for Lowest Cost QA System Read More »
Kyle Limoge joined AMA in 2005 and has a wealth of experience in process and specialty-gas piping quality control, with a focus on the biopharmaceutical and semiconductor industries. He is regularly tasked with managing third-party and subcontracted inspection efforts on large-scale, ground-up projects. Kyle is a NEBB CPT Certified Professional (License #CP-24271); he holds an …
In the environmental monitoring business, meeting scheduling demands and performing critical-path compliance testing in pharmaceutical manufacturing – where downtime is measured in minutes – is a welcome challenge on the best of days, requiring effective coordination with numerous equipment vendors and outside testing labs. This challenge was amplified for us when the global health crisis …
COVID19 Compliance, Keeping Ahead of the ‘Curve’ Read More »
With the recent spread of the COVID-19 virus, cleanroom containment and negative pressure environments are playing a key role in safely caring for the sick as well as keeping medical professionals and health care providers safe. COVID-19 is transferred through respitory droplets in the air and a properly designed, constructed, and certified negative pressure environments …
NEBB Certification – Cleanroom Performance Testing Read More »
The proper application of a QA/QC program in high purity systems can make the difference between meeting cost, schedule and quality … or not! In preparation for a recent project for a biopharma project in Florida, an experienced mechanical process piping installer wanted assistance with their QA/QC program before work started, and support in applying …
QA/QC Weld Program – Keys to Saving Time and Money Read More »
