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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.
The United States Pharmacopeia and National Formulary (USP-NF) has been the official compendia under the United States Food and Drug Administration (FDA) since the Pure Food and Drug Act of 1906...
21 February 2017 | By GE Analytical Instruments
This webinar demonstrated Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study for multiple, difficult to oxidise or low solubility organic compounds...
GE has announced the release of its new Sievers M9 Total Organic Carbon (TOC) Analyzer, which has been designed to measure TOC in a broad range of samples from ultrapure water to process waters. The new M9 Analyzer enhances productivity by producing TOC results in two minutes, twice as fast…
