Whitepapers

At Rite-Hite, we have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We keep up-to-date on best practices, new design and technology, and the latest trends in the industry.

This application note demonstrates the capabilities for Dual LC to run independent HPLC and UHPLC methods simultaneously using one instrument.

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation.

• Accelerated compliance for less expense. • Raman spec streamlines non-destructive processes for production/release

• Raman spectroscopy of streamlining pharma QC and formulation development • Implementing transmission Raman for fast content uniformity testing • Through-container identity verification of polysorbates 20, 40, 60, and 80

from A technical review of compounding, devolatilization, reactive processing, foaming and direct extrusion via twin screw extruders

This app note demonstrates the use of transmission Raman for the quantification of Warfarin in whole intact pharmaceutical tablets at 0.5% w/w with 20 s measurement time

Pharmaceutical companies require marked components for lot traceability but problems occur within secondary processing and with traditional printing methods.

Technology transfers helps sponsors safeguard supply, improve distribution and reduce program costs and risks.

Kidney transporter models are essential for identifying renal toxicity. Learn how immortalized primary renal tubule epithelial models stably expressing OAT1, OCT2 or OAT3 protein were tested for functionality.

This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.

In this white paper we look at reverse engineering existing drug products using Raman imaging.

Download the White Paper and learn how detailed characterization can guide successful development of gene therapy products.

Discussion of the transfer of analytical HPLC methods from a Waters Acquity UPLC system to the Vanquish platform and highlights the impact of column thermostatting.

This application note demonstrates how sensitive UV detection provides quantitation of a genotoxic impurity at low ng/mL level.

The Cubis® II balance series was designed for customizable modularity, which means the user can choose from many hardware and software options for thousands of different configurations. Meet the requirements of the pharmaceutical industry with a combination of the MCA high-end 7” display and specific QApp pharma package, providing all features needed for a full pharma-compliant lab balance system.

• How alternating tangential filtration differs from other perfusion methods • The benefits of alternating tangential filtration

Soft gel capsules are dosage forms that have an oblong and smooth casing that encapsulates a liquid. The soft gel casing (or gel-mass) is formulated by mixing together gelatin (or alternative material) with water, plasticizer and other ingredients. Historically, soft gel casings have been prepared in a batch mixing operation that takes many hours to complete.

Designing a formulation for a drug product calls for careful attention to both the physical and chemical properties of the active pharmaceutical ingredient. Find out how a pharmaceutical company can recognize both unfavorable drug substance properties and incompatibility between an API and its formulation to avoid potential risks to the patient and more.

ORC International’s report Implications of Inaccurate Forecasting on Biologics Drug Substance Manufacturing explores causes, consequences, and potential solutions to forecasting challenges related to biopharmaceutical drug substance manufacturing. It provides insight and perspective on key themes that emerge from the report, offering additional solutions to prepare for inevitable forecast inaccuracies.

Teams from the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, or JPEO-CBRND, provide continuing support to the Ebola virus outbreak response in the Democratic Republic of the Congo, or DRC, and neighboring countries.

Simplify the scaling of different dosages. Develop on lower dosage tablets to save money. Decrease the need to have multiple tooling sizes in R&D.

The purpose of this document is to serve as a case study where a containment device was designed to facilitate “interim containment”, or containment during the portion of a process where the product isn’t inside the enclosure.

Learn how you can bypass lengthy customizations by deploying a purpose-built LIMS. Pre-configured, pre-validated lab information management systems save time and money, reduce risk, keep you focused, and future-proof your lab.

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation.

Disinfection is not just about the disinfectant. The details, tools and protocols implemented in a facility determine if a disinfection program is successful. This paper reviews the details that are often overlooked but can make a big difference.

Identifying counterfeit drugs has become an area of increasing focus for regulatory authorities and also for pharmaceutical companies. Raman spectroscopy is highly specific and can differentiate between materials with similar chemical structures.