Pharmaceutical Cleanroom Construction And Project Management
AES utilizes a cross-functional project team from design through commissioning. This multi-discipline approach is dedicated to delivering a compliant facility. AES has strict quality, cost, and schedule expectations. The AES team is comprised of experienced personnel who have a full understanding of how to construct in a GMP environment and how to seamlessly transition a facility toward operational readiness.
TAKEONE® Aseptic Sampling System
Aseptic sampling devices are a critical component in an effective microbial control program. Samples collected with TAKEONE® are used to measure critical purity attributes such as bioburden, sterility and endotoxin levels and important process parameters like metabolites, nutrients, osmolality, pH and more. The TAKEONE® aseptic sampling device is a pre-assembled and single-use sampling solution. The 1,5" or 2" device has 5 or 9 fully-closed and independent sampling lines. TAKEONE® collects perfectly representative samples giving exact results with no risk of false positives.
Industrial Bench Scale For Food Manufacturing
Minebea Intec Miras® is a new generation industrial bench and platform scale. We have implemented an array of features to meet the majority of user requirements in industrial sectors.
The weighing capacities range from 6 kg to 300 kg with 3 platform sizes. Miras® platforms feature a rugged construction and overload protection for industrial applications.
YPrime eCOA Platform For Patient Data Collection
YPrime’s eCOA platform offers a combination of quality, speed and flexibility with the ability to support the unique needs of sponsors, sites and patient users. Design and functionality that drives better data quality, efficiency gains, faster decisions, less administrative burden, more project control and great user experiences – add up for big impact.
ERP Software for Candy Manufacturers
JustFood ERP software has been designed to help companies in the chocolate and confectionery industry operate more efficiently, comply with global food safety standards and grow their businesses. JustFood chocolate and confectionery customers are better able to set up custom quality audits, segregate allergens during production and trace raw materials from receiving all the way through to manufacturing.
WHITE PAPERS AND CASE STUDIES
TITAN MBR™ Microfiltration Provides Private Development Site With Water Reuse Capabilities
When developers of a condominium complex sourced wastewater treatment systems, it did so with two primary requirements: efficient land utilization and high effluent quality to meet stringent guidelines. State regulators advised the developers to discuss combining its wastewater system with the owner’s association of an adjacent housing development, whose existing wastewater treatment system was aging and required augmentation.
ERP: A Vital Tool For F&B Manufacturers To Establish Compliance Procedures
Non-compliance penalties are severe — one mistake can harm consumers, reputation, profits, and can lead to a shutdown in operations. This column explains how ERP can help keep you compliant.
Ensuring Compliance With Part 11: A Site’s Perspective
As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.
RF Filtering For 5G Millimeter Wave Applications
This white paper discusses mmWave 5G communications. The paper also offers a guide for available RF filtering options at these frequencies, review mmWave frequencies and their applications, and cover what filtering technologies will be available for use at mmWave frequencies.
Measuring Average Power Of Pulsed Lasers With Photodiodes
Recent development in VCSELs for applications in remote sensing, require measurement of average power during pulsed operation. When measuring average power of pulsed lasers, another mechanism may also affect the linearity of the photodiode. In this article we review this mechanism.
Managing Conflicts Of Interest In Clinical Research
Managing conflicts of interest in clinical research is a critical mission for many reasons.Here we discuss the need for conflict of interest policies, examine the role of an IRB in managing conflicts of interest, and review key elements an IRB’s policy should include.
Hospital Secure Messaging: 7 Lessons Learned
As I was going through the metal detector at the airport, I tossed my pager in the bin. The security official looked at me and said, “You work in healthcare, don’t you?” I asked, “Why do you say that?” She said, “No one else uses pagers except for people in healthcare.” Her comment struck me; I thought, Wow. She is totally right.
Advanced Clinical Achieves A Strategic Advantage With Veeva Vault eTMF
Contract research organization Advanced Clinical leverages Veeva Vault eTMF to run faster, higher-quality trials for study partners.
MBR System Treats Nut Processor’s High Strength Wastewater with Ease
The macadamia nut is indeed favored by many as a high quality nut, evidenced by its extensive use in desserts or simply as a premium stand-alone snack. One of the world’s leading producers of these delicious nuts produces more than 15 million pounds each year from its Hawaii processing plant.
Tips For Submitting Expedited Review Studies
Becoming familiar with the expedited requirements is a good way to ensure you can navigate the review process effectively. Set yourself up for success by reading 6 tips for submitting research studies for expedited review.
Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring
Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?
Solution Provider Submits Periodic Adverse Drug Experience Reports (PADERs) For A Multinational Specialty Pharmaceutical Company
Submission of PADERs to the FDA is required during post-marketing drug safety surveillance. Instill confidence in your results and regulatory submissions by partnering with an experienced partner.
In Suffolk, Administrator Wheeler Announces $225M Loan For Water Reuse Project In Virginia
Today, at an event in Suffolk, Virginia, U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler announced a $225M Water Infrastructure Finance and Innovation Act (WIFIA) loan to the Hampton Roads Sanitation District (HRSD).
EPA Awards $20.2M To Maryland For Drinking Water Improvement Projects
The U.S. Environmental Protection Agency today announced it has awarded $20,170,000 to Maryland for drinking water improvement projects throughout the state.
Cambrex Completes Acquisition Of CDMO Avista Pharma Solutions
Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), and finished dosage forms, today announced that it has completed the acquisition of Avista Pharma Solutions (“Avista”), a contract development, manufacturing, and testing organization, from Ampersand Capital Partners.
EPA Awards $33.9M To Pennsylvania For Drinking Water Improvement Projects
The U.S. Environmental Protection Agency today announced it has awarded $33.9M to Pennsylvania for drinking water improvement projects throughout the state.
EPA Administrator Wheeler Wraps Up Visit To Michigan
During U.S. Environmental Protection Agency (EPA) Administrator Wheeler’s visit to the Great Lakes State, he unveiled the Great Lakes Restoration Initiative (GLRI) Action Plan III at Belle Isle, addressed the Detroit Economic Club, and participated in a Detroit water and sewage roundtable.