Insights from Manufacturing & Quality Control

Operator performing a swab sampling on stainless steel equipment and checking TOC analyzer readings as part of MAC (Maximum Allowable Carryover) calculation in cleaning validation.

7-Part Series: Part 6 – Calculating MAC in Cleaning Validation

2025.06.12
Hello everyone. In this article, we will discuss how to calculate the Maximum Allowable Carryover (MAC), which plays a critical role in cleaning validation in the pharmaceutical industr… 黒澤伸行

Evaluating Cleaning Effectiveness in Pharmaceutical Manufacturing

7-Part Series: Part 5 – Evaluating Cleaning Effectiveness: The Role of Swab Recovery Rate Testing

2025.05.26
This time, we will discuss the feasibility testing of swab recovery rates for compounds. This test is designed to verify the recovery rate of Total Organic Carbon (TOC) analysis when dealing w… 黒澤伸行

Header image for an article on improving efficiency in cleaning validation using TOC, showing a technician in gloves performing surface swab sampling beside a TOC analyzer in a pharmaceutical manufacturing environment.

7-Part Series: Part 4 – A New Approach to Cleaning Validation: The Effectiveness of TOC

2025.05.12
Cleaning validation in the pharmaceutical industry plays a critical role in ensuring that manufacturing equipment is properly cleaned and free from residues before the next production batch. Ho... 黒澤伸行

Header image for an article comparing the costs of TOC analyzers and HPLC in cleaning validation, featuring laboratory equipment and a gloved hand performing surface swabbing.

7-Part Series: Part 3 – Cost Comparison Between TOC Analyzers and HPLC in Cleaning Validation

2025.04.14
Cleaning validation is a critical process in the pharmaceutical industry. Various analytical methods are used to confirm that manufacturing equipment is properly cleaned. Among these methods, Tot… 黒澤伸行

Header image for an article on cleaning validation in the pharmaceutical industry, showing a technician performing swab sampling next to a TOC analyzer in a GMP manufacturing environment.

7-Part Series: Part 2 – Cleaning Validation in the Pharmaceutical Industry: Importance of Analytical Method Validation for TOC

2025.04.01
In this article, we introduce analytical method validation for TOC in cleaning validation for the pharmaceutical industry. This innot… 黒澤伸行

Header image for an article on the forefront of cleaning validation, showing a laboratory technician in gloves performing swab sampling next to a TOC analyzer.

7-Part Series: Part 1 – The Cutting Edge of Cleaning Validation: An Efficient Approach Utilizing TOC

2025.03.18
In the pharmaceutical industry, cleaning validation is a critical quality control process that requires strict compliance with regulatory authorities. This series covers a wide range of practical topi… 黒澤伸行

Swab sampling on a stainless steel surface during cleaning validation

Efficiency Meets Accuracy: How the Sievers M9 TOC Analyzer is Shaping the Future of Cleaning Validation

2025.04.28
Cleaning validation is an essential process to ensure product quality and safety. In industries such as pharmaceutic… 黒澤伸行

Illustration of a futuristic cityscape featuring high-rise buildings along a river and circular towers covered with greenery in the foreground.

Transforming the Future of Pharmaceuticals with Digital Innovation: A New Era of Digital Twins and Pharma 4.0

2024.08.21
The demand for advanced technology in the pharmaceutical indus… 黒澤伸行