Archive

EU GMP Annex 1 FAQs – Air Speed Strategies for Unidirectional Flows

Details: Created: Monday, 10 June 2024 16:24

The following frequently asked questions arose at a presentation given by PMS Senior GMP Scientist, Mark Hallworth, on the 6^th of December on the topic of EU GMP Annex 1 Air Speed Strategies for Unidirectional Flows.

Why do manufacturers like ESCO, ThermoFisher Scientific, and Nuaire adopt different air speed values for 2A2 and 2B2 biological safety cabinets compared to the suggested range of 0.36 m/s to 0.54 m/s?

These manufacturers guarantee unidirectional airflow based on the speed ratings determined according to the specific equipment model. While the suggested range is 0.36 m/s to 0.54 m/s, the manufacturers may choose different values that they believe are optimal for their equipment.

Stability Analysis of Whey Based Beverages

Details: Created: Thursday, 07 March 2024 15:46

courtesy of DataPhysics

Whey Based Beverages - Stability analysis of whey based beverages 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,
such as, crystallization of lactose stored in the fridge, coagulation of whey proteins amongst others. It is of great importance to study the stability of whey beverage formulations and modify them towards a better performance. With the MultiScan 20 (MS 20) (Fig. 2) dispersion stability analysis system from DataPhysics Instruments stability
changes can be detected and evalauted in a quantitative way much faster than any traditional shelflife test would permit. The stability study of four whey beverage formulations is presented throughout this application note.

The Pamas S40 AVTUR

Details: Created: Thursday, 07 March 2024 15:10

courtesy of Pamas

The PAMAS S40 AVTUR is a portable particle counter for the analysis of turbine fuels and diesel. The S40 AVTUR has its own device-specific analysis method that is derived from the Energy Institute London standard IP 577. The S40 AVTUR instrument fully complies with DEFSTAN 91-091 and IP 630 (formerly IP PM FA).

A wear-resistant ceramic piston pump guarantees a constant flow. The simple-to-use touchscreen user interface makes operation easy and intuitive. The system is equipped with an integrated battery for more than three hours of operation and data storage of more than 4000 measurements. The samples can be taken from bottles without pressure or pressurised up to 6 bar. Real-time sample measurement data can be printed during the analysis and previous results retrieved and re-printed if needed at any time at a later date.

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10 Years of BioCapt® Single Use Impactor

Details: Created: Thursday, 07 March 2024 14:57

Microbial Data Collection environmental monitoring biocapt single use 10 years courtesy of Particle Measuring Systems

Particle Measuring Systems has recently announced 10 years of the Biocapt Single Use Microbial Impactor. This podcast specifically, covers the celebration of 10 years since its launch and its evolution and success, with a focus on its application in pharmaceutical production for microbial air sampling.

Measuring interfacial tension of insulating oil against water according to ASTM D971

Details: Created: Wednesday, 21 February 2024 14:12

courtesy of DataPhysics

Monitoring the degradation of insulating oil at an early stage is integral for detecting incipient faults within a transformer and avoiding catastrophic failures. The interfacial tension (IFT) is commonly considered to be an effective index for evaluating deterioration with increasing age, due to its high sensitivity to contaminants and impurities.

The ASTM D971 ^[1]: Standard Test Method for Interfacial Tension of Insulating Liquids Against Water by the Ring Method is a widely used standard method to examine the quality of insulating oil. In the following, the application of the ASTM D971 will be presented using a tensiometer of the DCAT series from DataPhysics Instruments.

How to Choose the Right Cleanroom Particle Counter

Details: Created: Wednesday, 21 February 2024 13:48

courtesy of Particle Measuring Systems

Maintaining a contamination-free environment is a prerequisite for high-tech manufacturing and scientific research. Cleanrooms are central to this endeavour. Although a cleanroom is a critical part of maintaining a working environment, they cannot guarantee required cleanliness standards without robust monitoring systems such as particle counters and air quality monitors. A cleanroom particle counter directly contributes to air quality by measuring the concentration of airborne particles in the environment, which is essential for quality assurance (QA) and compliance. Here is a guide on how to choose the right particle counter for your cleanroom

Sustainability at PAMAS

Details: Created: Wednesday, 21 February 2024 13:33

courtesy of Pamas

Sustainability is more than just a buzzword to us – it is a commitment. At PAMAS, we focus on environmentally aware activities including recycling and upcycling in order to save resources. Below is a selection of our actions:

Reuse of materials: We focus on reusing foils, packaging, cardboard boxes and insulation materials for shipping. This resource-saving practice helps us to minimise our ecological footprint.
Oil recycling: The oil used for rinsing and calibration is recycled in-house at PAMAS headquarters. Through this innovative practice, we create a closed oil cycle that requires less oil for disposal and instead enables the production of new clean oil or calibration suspension fluids.

The moisture sorption capacity for building materials

Details: Created: Tuesday, 23 January 2024 15:34

courtesy of Surface Measurement Systems

The moisture sorption capacity for building materials such as cement, wood, insulation material, and fibers has significant implications
on a building’s lifespan, as well as having a big effect on indoor air quality and air-conditioning loads.

How nature can inspire the development of new humidity and temperature controlled actuators

Details: Created: Tuesday, 23 January 2024 15:23

Actuator courtesy of DataPhysics Instruments

Pine cones only open when the weather is dry and warm; feather grass releases its seeds when the air humidity is high. Nature is full of environmentally adaptive materials
and has since inspired many man-made materials. In the field of building engineering, for example, temperature and humidity-dependent actuators are the key to
intelligent facades and roofs that can respond to changing weather conditions.

5 Key Principles of Cleanroom Particle Counting

Details: Created: Tuesday, 23 January 2024 15:12

courtesy of Particle Measuring Systems

Cleanroom particle counting is essential for accurate functioning and meeting certification criteria in controlled environments. In this blog post, we take a look at five key principles
of cleanroom particle counting, exploring the significance of each principle and how it contributes to maintaining the safety and quality of products manufactured in such environments.

Are the results you report accurate? They are with PAMAS!

Details: Created: Tuesday, 23 January 2024 14:43

courtesy of Pamas

Statement: PAMAS particle counter measurements are consistent, reliable, and repeatable.

A worldwide* round-robin test was carried out to prove this very statement. The aim was to compare counting results regardless of device type, continent, calibration material and human factor.

A round-robin test serves as a quality assurance check for the repeatability of a measurement at different locations. Identical samples are counted according to the same test procedure by trained external personnel in different laboratories. The vast range of instrument locations and collection of several results makes it possible to formulate a statement about the strength of the measurement method and the quality of the measured sample.

Environmental Monitoring Handbook for Pharmaceutical Manufacturers

Details: Created: Monday, 05 December 2022 15:41

courtesy of Particle Measuring Systems

Covering everything from the technology of particle counting to the regulatory standards that apply to the pharmaceutical
manufacturing industry to the instrumentation and techniques needed to meet them, this premier handbook helps readers
understand the topic of environmental monitoring more holistically and more extensively. With the release of the much
anticipated EU GMP Annex 1 2022 standard, the pharmaceutical manufacturing industry is entering a new era of regulatory
requirements. Discover how the new Annex 1 standards and the adoption of a CCS fit into the larger picture of the industry by
downloading the handbook now!