GMP洁净室污染监测的十条实用建议
无菌生产中的压缩气体系统
为何定期对颗粒计数器进行校准和维护能保障洁净生产
BLOG: The Data Quality Concept for Pharmaceutical
The role of data quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality Experts in areas such as validation, product release, operations, sterility assurance, and other…
BLOG: USP 788 vs 1788: How do They Compare?
Why the USP 1788 update? New flow imaging technologies and therapeutic protein solutions widened the scope of USP 1788. Three primary technologies are discussed in each of the sub-parts of the guidance document: Light Obscuration (LO) is still the preferred first-pass method for the USP Normative chapters. If a solution is…
BLOG: Chemical Batch Sampling to 20 nm with the SLS-20
Chemical Batch Sampling Use Case Studies #1 The SLS-20 and Chem 20 system has been tested to sample contamination down to 20 nm in chemicals ranging from sulfuric acid to organic solvents. In this blog, we will be taking a look at the following process chemicals: Sulfuric acid PGME, PGMEA…
将原始粒子计数转换为归一化粒子计数
PMS outlines the basic methods of reporting data from aerosol particle counters and understanding how to appropriately apply data conversions.
Cleanroom Cleaning & Disinfection Per Annex 1, rev 12
The latest Annex 1 draft offers several updated expectations on cleanroom cleaning, decontamination and disinfection. Learn about these expectations and addressing them with a contamination control strategy (CCS) Definitions Cleaning (NEW)A process for removing contamination e.g. product residues and disinfectant residues from a cleanroom. Decontamination The overall process of removal…
选择最适合您的粒子计数器系列三：监测点数量（共四部分）
In this blog series, we take a look at common terms and initial considerations for selecting an aerosol particle monitor for various applications.
选择最适合您的粒子计数器系列一（共四部分）
In this blog series, we take a look at common terms and initial considerations for selecting an aerosol particle monitor for various applications.