Microbial Sampling Criteria
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- Created: Monday, 16 September 2024 14:23
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In the pharmaceutical 
manufacturing industry, ensuring sterility and minimizing microbial contamination are critical for maintaining product quality and safety. Microbial sampling is a key component of environmental monitoring, and understanding the optimal criteria for sampling can significantly impact the effectiveness of sterility assurance programs.
Introduction to Microbial Sampling Methods
In a pharmaceutical manufacturing facility, microbial sampling is conducted using several methods, each with its own set of instruments and techniques. The primary methods include:
- Surface Sampling: Typically performed using swabs or contact plates to collect microbes from surfaces.
- Passive Aerosol (Air) Environmental Sampling: Involves the use of settle plates to capture airborne particles that settle over time.
- Active Aerosol (Air) Environmental Sampling: Utilizes devices that actively draw air through a collection medium, such as an impactor, to capture airborne microorganisms.
Surface Measurement Systems
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Ion-exchange membranes are widely used in numerous applications, such as water treatment, chemistry, electrolysis, sensorics and other fields. A good ion transfer selectivity of the ion-exchange membrane is highly important for all of these applications. The charge structure and composition of ion-exchange membranes has a strong influence on the mobility of different ions or molecules and thus governs the selectivity of ion transport processes through the membrane.[1] Therefore, it is of great importance to have a good technique to characterise the charged surface functionalities of ion-exchange membranes. A powerful technique to evaluate charged surface functionalities is the measurement of the zeta potential, that is, the electric potential of solid surfaces in contact with an electrolyte solution. With this information it is possible to better understand the dissociation state of functional groups on the surface, and conclude the electrostatic interactions that will occur with other materials such as charged particles. The new Zeta Potential Analyzer ZPA 20 from DataPhysics Instruments (Fig. 1) measures the zeta potential of fibres, powders and plate shaped surfaces by means of a novel bidirectional oscillating streaming potential or streaming current technique. In this application note, we study the functional groups of different ion-exchange membrane surfaces with the ZPA 20.
Particle counting efficiency is crucial in particle measurement, especially when using optical particle counters. This term denotes the likelihood of precisely detecting and enumerating particles within a specified size spectrum. In this context, the term “particle counting efficiency” represents the ability of the particle counter to quantify particles of a given size accurately. It measures the instrument’s performance, indicating how effectively it can detect and count particles of various sizes.
DataPhysics Instruments has launched a world first, the PCA 200 Portable Contact Angle Goniometer - a fully autonomous device for determining the surface energy. Developed as an alternative to test inks for quality control and production, it employs a quantitative, reproducible measurement methodology. The PCA 200 enables the non-destructive testing of surfaces of any size, occupying no more space than a typical digital camera.
This study investigates the chemical degradation and dehydration behaviours of pharmaceutical compounds, acetylsalicylic acid (ASA) and citric acid monohydrate, used in drug formulation, stability, and drug delivery systems. The combination of DVS and Raman spectroscopy reveals changes during ASA degradation, influenced by humidity and temperature. Analysing the process of dehydration of citric acid monohydrate is important when understanding drug release mechanisms. This has been shown to be affected by temperature and humidity, with higher humidity necessitating elevated temperatures to produce its anhydrous form. Understanding the changes and kinetics involved in these processes can influence decisions in pharmaceutical design, enhancing drug efficacy and shelf-life.
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Selecting the right monitoring technique is pivotal in cleanroom contamination control. These specialized environments demand rigorous standards to ensure product integrity and safety. They are, after all, responsible for some of the most hygiene-critical applications on earth, from pharmaceutical manufacturing facilities to semiconductor fabrication plants.
A bold new addition to the Inverse Gas Chromatography (iGC) line of Surface Energy Analyzers, the iGC-SEA Nova 
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The PAMAS SBSS is the standard instrument used as a reference in many testing labs. 
Maintaining environmental contamination control is one of the objectives of regulatory guidelines for the pharmaceutical field. As outlined in the EU GMP Annex 1 regulatory standard for sterile drug products, a Contamination Control Strategy (CCS) is a way to outline a method to identify and analyze risk, review the mitigating opportunities and innovations, and ultimately define corrective and preventive action plans. Implementation of a CCS attempts to address the varied causes of contamination and compromised sterility.
Whey drinks area popular ready-to-drink protein beverages, owing to their excellent nutritional qualitiest and good flavor. To have a fresh and neutral taste, whey based beverages are usually prepared with fruits or vegetables. Stability issues are one of the major problems which are commonly encountered in this kind of beverages,
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Statement: PAMAS particle counter measurements are consistent, reliable, and repeatable.
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You can measure the cleanliness of components and packing materials with an automatic particle counter. The surface cleanliness is analysed indirectly by
Solubility is a critical consideration across a wide range of industries. 
Pinpointing a particle source can be a challenge in cleanrooms and laboratory flow equipment where the movement of clean air (which is the purpose of the air handling system) can mask particle generators such as faulty filters, motors, robots, operators and residual dust. 
Matter under ambient conditions interacts with moisture and volatiles continuously. Exposure to heat and a high airflow over material will induce some form of drying. A material’s ability to resist rapid transitions between wet/hydrated states can be a good measure of stability.
The cleanliness control of hydraulic fluids is a typical application of optical particle counting with the aid of an Automatic Particle Counter. Hydraulic fluids are used for the transfer of energy in hydraulic systems. For smooth operation and uninterrupted maintenance of functionality, it is essential that the operating liquid is regularly controlled; a high degree of contamination could cause a malfunction within a component and may also lead to a complete system break-down. 
Annex 1 is a regulation that outlines manufacturing requirements for sterile drugs made in and imported to the EU. In August 2022, a new revision of the EU GMP Annex 1 regulatory standard for sterile drug products was released, replacing the most recent draft from 2020 and the existing revision from 2008. Contamination control is vital in pharmaceutical manufacturing, and the requirements for environmental monitoring remain essentially the same in this revision; changes in the recent revision of Annex 1 highlight strategic control through further alignment with existing regulations from other organizations, the concept of a contamination control strategy (CCS), the separation and expanded guidance on Cleanroom Classification and Cleanroom Monitoring, and the definition of Quality Risk Management (QRM) as a central principle to defining processes, operations, and limits.