Pharmaceutical Production & Laboratory

White Paper

Central Monitoring Systems 101: Easier Management and Better Control of Critical Assets

A central monitoring system provides a solution for automated continuous monitoring. It will enable your facility to have fast, standardized responses to alarms and efficient, electronic reporting capabilities, adding a superior level of protection for your irreplaceable products. 
→ Download White Paper

GDP for APIs New Regulations

APIs, drug substances, starting materials or excipients… any name you give them, are now under strict GDP regulations to handle carefully, within temperature specification from the point of manufacturing at the API plant. This article will discuss 2015 bottom-line regulatory requirements for API suppliers and manufacturers – and what pharma manufacturers can do to ensure procurement of quality materials.
→ Download White Paper

Temperature Data: The Underrated Superhero for Research Labs, Pharmacies & Healthcare Facilities

When freezers, incubators or refrigerators experience a temperature excursion, the cost could be irreplaceable research samples lost or expensive medicines spoiled. The right alarm/monitoring system can protect against product loss, but with so many solutions on the market, which monitoring solution is ideal? This article discusses the importance of having a comprehensive monitoring solution that includes remote alarm capability, data logging and an independent sensor and why these three features are critical.
→ Download White Paper

Could Poor Temperature Data Management be Putting Your GxP Facility at Risk for Data Integrity Violations?

Did you know that 95% of data integrity problems arise inadvertently due to poor data management? Not intentionally, or corruptly, like the news likes to portray. Using old technology, especially in paper form like chart recorders or printed reports, increases risk in your laboratories that some error will be made in collecting, storing or retrieving in data. Moving to electronic data monitoring will help you automate processes and intelligently manage data while meeting new data integrity requirements from MHRA, WHO and FDA.
→ Download White Paper

Transitioning to an Enterprise-CMS (Environmental Monitoring System) in a Regulated Environment

If your facility is growing or has come under the purview of GxP regulatory review, you know that data is the critical for healthcare facilities like hospitals to comply with JCAHO or Pharma to comply with FDA 21 CFR 11. Regulators want to see evidence that demonstrates maintenance of correct environmental conditions for healthcare related materials and products being stored in a facility.
→ Download White Paper

Warehouse Mapping of GxP Storage Facilities: Why it’s Not an Option

When your warehouse stores temperature sensitive pharmaceuticals and life science products, a top of the line HVAC system with carefully placed thermostats is not enough to ensure product quality and consumer safety. Why? It is the nature of warehouse facilities, no matter the size, to experience temperature gradients.
→ Download White Paper

Losing Everything: Is a Chart Recorder Enough to Protect Critical Assets?

Environmental / temperature monitoring plays a vital role in the manufacturing (cGMP) and healthcare (JCAHO, CAP, USP 797) markets. In the event of a temperature excursion, do you know if your product is still acceptable? Would you lose valuable product or days worth of testing time?
→ Download White Paper

Case Study

Bayer CropScience

Bayer’s Crop Science division is committed to food security with a focus on innovative crop solutions, seeds and traits to increase productivity. The Innovative Center for Seed & Trait Safety in Belgium has a network of 50 freezers and refrigerators that are used to store products, reagents, DNA and proteins. Bayer CropScience partnered with ELPRO to implement a GLP compliant monitoring system that could be fully validated, streamline all data and event reporting and send remote notification in the event of a freezer alarm.
→ Download Case Study

Endocyte

Endocyte is a biopharmaceutical company seeking to maximize the potential of small molecule drug conjugates (SMDCs) with companion imaging agents. Endocyte has a large network of 53 monitoring points that requires a regulatory compliant central monitoring system that enables them to react to alarms quickly and give complete insight to all labs and equipment storing their irreplaceable materials.
→ Download Case Study

Center for Regenerative Medicine (ZRM)

ELPRO’s Central Monitoring System (CMS) enables reliable recording of all relevant data in the cleanroom. Differential pressure, temperature, relative humidity, CO2 concentration and the particle concentration can be recorded and saved continuously.
→ Download Case Study

Site Monitoring Kit

No more daily manual temperature inspections and paper min / max lists which are unreliable and difficult to archive. One brief check once a week and one monthly download is all the site staff needs to do.
→ Download Case Study