List view / Grid view
Pharma 4.0 is coming and is further driven by the recent update of the EU GMP Annex 1 regarding manufacturing of sterile medical products, setting new regulatory expectations in all manufacturing processes. Here, Isabella Jul-Jørgensen from the University of Denmark focuses on sterile water quality and how the new requirements…
Study finds several variables can significantly increase the sampling error in total organic carbon (TOC) swab testing used for pharmaceutical cleaning verification.
Could ELGA’s PURELAB® Pharma Compliance reliable, intuitive and simple to use GMP ready system be the future for your ultrapure water needs?
Cleaning validation is an important element to current good manufacturing practice (cGMP) manufacturing to ensure purity, quality and potency of drug product. Above all, patient safety is the primary concern.
This expert view from SUEZ discusses how total organic carbon (TOC) and conductivity monitoring are crucial aspects of purified water system quality and control.
Cleaning validation is an important element to cGMP manufacturing to ensure purity, quality, and potency of drug product.
A typical cleaning validation (CV) programme consists of three phases: Design, Validation and Continued Verification.
In the wake of Brexit, the pharma industry will need to respond to a new regulatory landscape. Peter Morgan discusses how businesses have to prepare for the oncoming political changes, all whist retaining high pharmaceutical product quality.
The purpose of this Technical Communication is to establish how General Chemistry Data obtained in controlled extraction studies, such as pH, UV absorbance and total organic carbon (TOC), is reported, used and discussed as part of a rigorous extractables assessment.
To ensure that USP/EP standards are met, TOC of highly purified water can be determined by internal purification-process monitoring.
This application note from SUEZ outlines the factors that companies should consider when choosing their cleaning validation procedure, highlighting the benefits of TOC analysis over HPLC.
18 April 2019 | By SUEZ
TOC analysis is a widely adopted method for detecting residual product or cleaning agents on manufacturing equipment. Compared to specific methods such as HPLC, TOC can provide better process understanding and efficiency for cleaning validation (CV), verification and continuous monitoring...
A brief overview of how SWAN Analytical Instruments helps to ensure water quality with analysers to measure trace ozone and total organic carbon (TOC).
22 January 2019 | By SUEZ
Register for our latest webinar on the proposed Annex 1 revision on pharmaceutical water to prepare for future compliance...
Designing a robust cleaning process for pharmaceutical drug manufacturing is critical to successful cleaning validation and verification.
