Raman spectroscopy is a proven tool for in-line process monitoring and control. It can be used to quantify concentrations of chemical compounds online and in real-time. High-performance Raman spectroscopy, made possible by Tornado Spectral Systems’ patented High-Throughput Virtual Slit (HTVS™),...
Technological developments in the pharmaceutical industry have advanced
rapidly over the last decades. One field of particular interest has been aseptic and sterile primary packaging. Primary packaging of pharmaceutical products often involves filling containers (including vials, syringes...
Nucl3o announced today that it was named as the “Best Hemp Based Extract Company - Southwest USA”. Awarded by Global Health & Pharma, this honor recognises excellence for services within the healthcare and pharmaceutical industries.
The product specification are given in the attached document
The product is produced in China in compliance with USP41.
GMP is available on request.
Product application: commonly used as the main component of compound preparations for gastrointestinal anti-acid drugs that used to treat...
Drug development requires an average overall investment of USD 1.5 – 4.5 billion and remains at high risk due to the huge attrition rate phase after phase [1; 2]. The pre-clinical development phase and the phase 1 clinical trial show the highest attrition rate due to toxicity or drug metabolism...
In pharma, quality is a high-stakes business — not only measured in dollars, but more importantly, impacting patient lives. This eBook will discuss what it takes to achieve consistent quality in a changing manufacturing landscape.
Gain insight on:
- How new AI applications can automate the...
In formulation development, the scale-up from a lab-bench production of small batches to a large-scale production due to a demand for bigger batches, e.g. for clinical trials or economic reasons, can often be challenging. Thus, the possibility to scale-up the manufacturing process is imperative...
When a label on a bottle says “100 tablets”, we assume there are 100 tablets inside, don’t we? Not 99 or 101, but exactly 100. To be more precise, it is expected that the bottle contains exactly 100 undamaged tablets of the same kind. Obviously, bottle filling technology must meet two bigger...
With tightening regulations and rising costs, the pharmaceutical industry is being presented with a consistent challenge in the marketplace: Do more with less. As a result, pharma companies are reducing their internal capacities in manufacturing and R&D and are, instead, increasing their...
In the biotechnology and pharmaceutical industries, hygiene, consistent performance and flexibility are
decisive factors for efficient, as well as safe production with a high degree of automation. VEGA offers worldclass measurement technology for level and pressure. We are specialists in this area.
Water hammer can be so damaging to machinery and dangerous to human health that every effort should be taken to prevent the hazard. Also known as hydraulic shock, water hammer sounds like a mechanical noise and is sometimes perceived to be a valve slamming closed. In reality, it is a phenomenon...
Two commonly used drugs in urology, Mitomycin and Gemcitabine, are included on the NIOSH list. As hazardous medications, USP 800 requires significant investment to safely compound and administer doses of these drugs. Edge Pharma developed a solution that solves this issue for hospitals, surgery...
A customer contacted Freund-Vector asking for a requirement to coat tablets on a LDCS-Pro Hi Coater (150L batches) and needed contained loading, sampling and unloading of their tablets.
Lack of data integrity is the main reason for most FDA warning letters.
For laboratories that must comply with GLP, GMP and GAMP regulations it is important to have records or documented evidence of all relevant analyses that can be checked by a second person and are also readily available...
The importance of polymorphism in the pharmaceutical industry is well established. Much literature exists describing the effect of polymorphs on efficacy, the phenomenon of polymorphism, and the analytical tools available to study polymorphism in active pharmaceutical ingredients and drug...
We suggest that containers which are not produced to a recognized standard of cleanliness are a potential source of contamination.’ This article discusses why this is a problem for biopharmaceutical and vaccine manufacturers, the nature and source of possible contaminants, and a readily...
To make the products safe for water distribution there must be protective
barrier material, joining, and sealing materials. These materials will ensure
that the water remains free from any contaminates that may be present on
or in the metal, paint, gaskets, lubricants, etc.
NSF/ANSI has...
Top loading packaging experts Dividella have adopted the ‘Lot Size One and Up’ approach rooted in Pharma 4.0 concepts. This is based on a robotic work-cell system that boosts the flexibility and sustainability of small-lot production to relieve stress points for pharmaceutical manufacturers...
Key Differences Between Data Logging and Data Acquisition
What is the difference between a Data Logger vs DAQ System? A data logger is a type of data acquisition system, but a data acquisition system is not necessarily a datalogger. There are several key functional differences in how the market...
Ocean Optics went from a 4' x 6' humble beginning to a premier developer and supplier of the "World's First Miniature Spectrometer" Innovative engineering and equally innovative marketing are part of the "How we did it" story.
Formulation and process development for injectable products are typically conducted at laboratory-scale. There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilization. The...
The purpose of this guide is to walk US-based clinical supply professionals through the labeling requirements laid out in Annex 13 of the EU GMP guidelines. This annex details guidance for Investigational Medicinal Products (IMPs), and this handbook will focus only on those Articles applicable...
This white paper explains the theory behind the MCA algorithm
methodology. Then, used in tandem with in-situ fiber optics, the accuracy of the technique is demonstrated by recovering the concentration of two APIs in known mixed solutions. Finally, an example is given of accurately monitoring...
In this article Dr Richard Johnson, Founding Director of Upperton Ltd, describes some of the basic principles of spray
drying and how spray drying is typically being used in the pharmaceutical and biotechnology industry. Particular attention
is focussed on four key applications, namely the...
An ERP solution developed for small to mid-sized nutraceutical companies that use batch process manufacturing
needs to go beyond the basics of an accounting and Microsoft Excel-based system, or even a one-size-fits-all ERP
solution. An industry-specific ERP will provide you with a higher level...
Expectations include:
• Understanding products and processes in order to implement Quality by Design (QbD) into product development
• Delivery of quality metrics for risk-based inspection schedules as proposed by a new quality metrics program
• Shared responsibility for products manufactured...
As the Drug Quality and Security Act’s (DQSA’s) Novem- ber 2017 deadline approaches for serializing saleable units of prescription pharmaceuticals, many pharmaceu- tical companies, particularly small to mid-size organiza- tions, are just embarking on the serialization journey.
There are four...
Proper chemical storage is critical to minimizing risk in a laboratory or industrial setting. The safe storage of hazardous substances is an essential part of any environmental, health, and safety program for your lab. To minimize liability and reduce the risk of an accident occurring it is...
The electronic, high-tech, semiconductor, pharmaceutical, aero space, medical and many other industries depend on cleanroom technology. As products such as cell phone circuit boards become smaller, the chance of contamination in manufacturing becomes higher. For pharmaceutical companies, clean,...
There are many factors to consider when selecting the right data logging solution for your specific needs and application. MadgeTech offers top of the line data loggers, accessories, systems and advanced data logging software. Since MadgeTech engineers and manufactures all of the data loggers...
Blow-fill-seal technology, originally developed in Europe in the 1930s and introduced in the US in the 1960s, has emerged as a preferred method for aseptic packaging of pharmaceutical and healthcare products due to unrivalled flexibility in container design, overall product quality, product...