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USP 797 Revision and Impact

The published changes to the chapter are to continue preventing harm through microbial contamination, excessive bacterial endotoxins and inappropriate quality of ingredients. Additionally, USP 797 was updated to reduce risk associated with unintended physical and chemical contaminants, as well as variability in intended strength. Currently, USP 797 is enforceable by the U.S. Food and Drug Administration, as well as 28 State Boards of Pharmacy.

Paper

Effective Risk Assessment in Pharmaceutical Manufacturing:
Steps to Ensure a Successful Audit

A risk assessment for pharmaceuticals is the first critical step when designing a contamination control for aseptic manufacturing. Product quality is the critical measure of success.

Paper

Data Management Series 2 – Risk Analysis of a Facility Monitoring System

An effective risk analysis provides Facility Monitoring System (FMS) users with the peace of mind that their data is secure and their system operative even in the event of an unforeseen situation. Here we discuss how to perform a risk analysis of an FMS system that uses the architecture of industrial automation design.

Paper

Microbial & Particle Risk Assessment of a Cleanroom & Filling Line Contamination

Filling Line Contamination can be generally avoided through an effective contamination monitoring system, starting with a risk assessment.

Paper

Aseptic Environment Monitoring: Manage Your Risk

For Aseptic Environment Monitoring, a risk assessment helps to meet the expectations of auditors.
Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards. The risk assessment of particle and microbiological contamination of the product and its components should take into account the following aspects: …

Paper

Risk Assessments as a Process Quality Assurance Tool

Environmental contamination control is a critical component of sterile pharmaceutical manufacturing, and Risk Management is necessary to ensure that the correct control practices are in place. The Risk Management process is a series of steps, including risk assessment, that allows for a deeper understanding of the manufacturing environment. Removing, reducing, or monitoring activities associated with a product or process to mitigate risk may be the result of such an assessment. This qualitative risk assessment can be transformed into a quantitative evaluation using modern risk analysis tools and procedures; these tools deliver the fully documented rationale behind the path chosen.

Paper

biocapt single use for annex 1 continuous monitoring

Key Factors for Optimizing Microbial Air Sampling

Microbial air sampling in pharmaceutical manufacturing relies on surface, passive, and active methods—each using media like agar to capture microbial growth. While techniques vary, accurate results depend on collection efficiency. This paper focuses on active air sampling and how to optimize performance across all methods.

Paper

Data Analysis to identify Particles in Chemicals

Particle Contamination in Chemical Distribution Systems

Particle contamination in chemical distribution systems can be difficult to find, but costly to yield when missed.

Paper

20 nm Chemical Batch Sampling Solution

Particle Measuring Systems (PMS) offers the Chem 20™ as the world’s most sensitive particle sensor, propelling online particle specification down to 20 nm for the first time. The SLS-20 syringe sampler, combined with the Chem 20, provides the flexibility of offline batch sampling for a variety of applications, including process chemical research, production, distribution and packaging.

Paper

Understand and Mitigate Variability
in Particle Counter Results

Establishing and maintaining cleanroom performance of aerosol particles in a cleanroom often requires the use of multiple particle counters with varying design parameters and display settings. Commonly, cleanroom personnel employ the use of multiple optical particle counters (as defined in ISO 14644-1) to report an array of airborne particle counts. This paper is a summary of the basic methods cleanroom personnel may use to ensure that the data that is reported by different aerosol particle counters can be compared effectively. This is accomplished by making sure differences are understood and appropriate data conversions can be made to make meaningful comparisons.

Resources Search Results

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USP 797 Revision and Impact

Effective Risk Assessment in Pharmaceutical Manufacturing:
Steps to Ensure a Successful Audit

Data Management Series 2 – Risk Analysis of a Facility Monitoring System

Microbial & Particle Risk Assessment of a Cleanroom & Filling Line Contamination

Aseptic Environment Monitoring: Manage Your Risk

Risk Assessments as a Process Quality Assurance Tool

Key Factors for Optimizing Microbial Air Sampling

Particle Contamination in Chemical Distribution Systems

20 nm Chemical Batch Sampling Solution

Understand and Mitigate Variability
in Particle Counter Results

Without measurement there is no control®

Resources Search Results

Search Knowledge Center

USP 797 Revision and Impact

Effective Risk Assessment in Pharmaceutical Manufacturing: Steps to Ensure a Successful Audit

Data Management Series 2 – Risk Analysis of a Facility Monitoring System

Microbial & Particle Risk Assessment of a Cleanroom & Filling Line Contamination

Aseptic Environment Monitoring: Manage Your Risk

Risk Assessments as a Process Quality Assurance Tool

Key Factors for Optimizing Microbial Air Sampling

Particle Contamination in Chemical Distribution Systems

20 nm Chemical Batch Sampling Solution

Understand and Mitigate Variability in Particle Counter Results

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Without measurement there is no control®

Effective Risk Assessment in Pharmaceutical Manufacturing:
Steps to Ensure a Successful Audit

Understand and Mitigate Variability
in Particle Counter Results