The Sorption Bulletin series is back – get the latest release free now

courtesy of Surface Measurement Systems
Surface Measurement Systems are happy to announce the return of their hugely popular Sorption Bulletin series, starting with the release of the Sorption Science Directory 2019 (DVS Edition).

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Langmuir trough module for DCAT 25

dcatHave you ever thought that you can add a Langmuir-Trough for the measurement of Surface Pressure to your standard Force-Tensiometer? This  feature you can find within the DataPhysics Instruments DCAT 25 accessory range.

 

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The Benefits of Handheld Particle Counting with the HandiLaz® Mini II

courtesy of Particle Measurement Systems

Modern manufacturing frequently requires clean environments such as cleanrooms that are designed, constructed, and sustained to enable the highest yields possible while also hitting predictable throughput targets. This commonly involves achieving a specified cleanroom classification to establish the level of cleanroom performance, and subsequent sustaining efforts that are efficient and nimble. Having the right particle detection equipment for this application is necessary to accomplish these tasks.

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Specialist liquid particle counting solutions from Pamas

An enquiry the other day for a B-ratio particle count analyser reminded me about the extensive range of specialist solutions Pamas GMBH offers. In this short article I will try to introduce you to some of them.

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Particle Measuring Systems Releases Next Generation Remote Particle Counter

courtesy of Particle Measuring Systems

The IsoAir® Pro-E Remote Particle Counter from Particle Measuring Systems (PMS) leverages the latest technologies to streamline cleanroom monitoring while meeting global regulations including EU GMP Annex 1, ISO 14644-2, and is part of a 21 CFR Part 11 solution. The robust 316L stainless steel enclosure is liquid resistant with an IP65 rating which protects the unit during cleaning and disinfection activities. This is the first particle counter with built in vacuum designed for use with the Vaporized Hydrogen Peroxide (VHP) process.

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Testing unknown samples

Over the last 20 years I came across several incidents where one of our customers decided to test a sample normally as a favour for another department , a friend or external company. Like that one advert says "what can go wrong" ?

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Safety in oil transformers due to PAMAS particle counters

Replacing Settle Plates with Active Air Sampling

Settle plates were adequate in the past to meet regulations, but the new approach requires active air sampling.

mobileActive Air Sampling for settle plates by Particle Measuring SystemsThe most universally applied method for cleanroom classification is the one suggested in 1963 by Federal Standard 209 of the USA. In this standard the number of particles equal to and greater than 0.5 µm is measured in one cubic foot of air. This count is then used to classify the room (1 particle = class 1; 10 particles = class 10…). In the same period, scientific publications concerning healthcare facilities suggested that airborne particles carrying micro-organisms associated with human disease were usually found in the 4-20 µm equivalent diameter range. This contamination can be detected by settle plates.

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The importance of local support and calibration

Micron Scientific offer local calibration and service on most of the instruments we supply. We are frequenlty contacted by competitor users to calibrate their equipment. Especialy in South Africa it is important to ask your service providor before you purchase a new laboratatory instrument if they will service and calibrate it locally or send it overseas for calibration.

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PAMAS SBSS - reference instrument for liquid particle counting

SBSSnewcourtesy of Pamas GMBH
The PAMAS GMBH SBSS particle analysing system is a tried and trusted  measuring instrument for laboratory particle counting. Using measuring data provided by fluid samples with known particulate contaminant, PAMAS has proved the repeatability of its particle counting systems.

Comparison of repeat measurements clearly show that the results of different measurements of the same fluid sample scarcely deviate from one another. Many renowned laboratories appreciate the extremely high measuring accuracy of PAMAS particle counters and in turn, manufacturers of conventional particle counters use the PAMAS SBSS particle analysing system as a reference for their calibration. 

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The Pamas SBSS - a user perspective

SBSSvidRecently I had the opportunity to use a Pamas SBSS ( Syringe Bottle Sampling System) at a customer. The instrument is the flagship liquid particle counter from Pamas GMBH.

What struck me immediately is how easy the instrument is to use! I am so used to controlling an instrument via software and PC these days, it is almost a novelty to just control the instrument via a touchpad! 

It has a simple menu system that allows the user to operate the instrument directly ( ofcourse normal software control via PC is also possible).

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Monthly webinars by Surface Measurement Systems

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Surface Measurement Systems has been very active in the last couple of months with a range of webinars covering a range of topics from Amorphous Content Calculations using dynamic vapour sorbption(DVS) to Advanced vapor sorption applications for pharmaceutical materials and a host of topics in between .

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PAMAS S40 - a milestone in the company's history

text supplied courtesy of PAMAS

PAMAS40bOnline and offline, at ambient pressure and under high pressure, in the laboratory or in the field - the versatility of the PAMAS S40 is evident and testifies to the years of continuous development work that has ensured that PAMAS has long been the world market leader in the field of particle measurement.For almost 30 years, PAMAS GmbH has been manufacturing automatic particle counters for liquids that can determine in a matter of minutes whether and to what extent a liquid is contaminated. A milestone in the history of development was laid with the introduction of the PAMAS S40 in 1999 . 

 

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Data Trending Requirements Annex 1, Rev 12

 Written by 

Data Trending and Alert/Action Levels definition are new requirements in the latest EU GMP Annex 1, Revision 12 draft. Trends allow you to quickly and easily identify changes in your cleanroom data and leverage this to make effective decisions, changes, and adjustments often before problems occur. Here we discuss three key components in the latest Annex 1 draft:

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Continious Viable Air Monitoring per Annex 1 Draft, Rev 12

Continuous viable air monitoring is now a consideration, or even a recommendation o  the new sections of Annex 1 draft, rev 12. Here I discuss this as well as the overall environmental monitoring requirements as part of Particle Measuring System’s series on the newest Annex 1 draft. Learn what Annex 1 is saying it will

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Particle measurement of therapeutic protein solutions

bagtext supplied courtesy of PAMAS

Have you ever tried to perform particle measurement of therapeutic protein solutions? You will encounter several challenges.  There is extremely limited sample available because  therapeutic protein solutions are very expensive. In addition, the samples are usually highly viscous. How can reliable values be measured without diluting the samples or having to resort to the subjective and time-consuming microscopic analysis?

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Design of robust superhydrophobic surfaces

courtesy of Dataphysics

OCA200The properties of superhydrophobic surfaces are highly desirable in many industries and applications. Unfortunately these surfaces often suffer from low durability. They are for example easily scratched by hard objects and their superhydrophobicity is destroyed.

In the latest Nature cover story Wang, D., Sun, Q., Hokkanen, M.J., Ras, R.H.A. et al. introduce a new strategy to create superhydrophobic surfaces that have a high mechanical stability. They designed a material matrix that combines the superhydrophobic nanostructure with a highly durable macrostructure. This new material can be even scratched with a razorblade or with sandpaper without losing its superhydrophobic properties. Due to its transparent nature the new material matrix is an ideal candidate for a new kind of self-cleaning cover material for solar panels.

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Professor Daryl Williams wins Prestigious Royal Society of Chemistry Award

text supplied by Surface Measurement Systems

Professor Daryl Williams has been named the winner of the Royal Society of Chemistry’s Chemistry World Entrepreneur of the Year.

Based at Imperial College London and Surface Measurement Systems Limited, Professor Williams won the award for the pioneering invention of the Dynamic Vapour Sorption (DVS) instrument, which has transformed research laboratory practice worldwide.

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Selecting the Best Particle Counter for Your Needs (Series Part 1 of 4)

Written by 

Particle Counter Terminology and Standards

Your need to find the best particle counter for your application depends on monitoring environment, communications, desired flow rate, and the particle sizes of interest. Don’t know where to start? Read on for an overview of the basics for choosing the method to monitor your process air.

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Increased safety in air travel with PAMAS

text supplied by Pamas

In the event of a drop in pressure on board of an aircraft, oxygen cylinders are the safety solution for all passengers and crew. Unfortunately, these lifesaving components can be fatal if the maintenance carried out is incorrect or substandard. This happened in 2008.

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Beginner Guide to Particle Technology

The first in a three part series, this Particle Counting Technology Guide covers the basic details and concepts around particle monitoring and controlling particle contamination. Written by the global experts in contamination monitoring, in a simple to follow format, this particle counting guide has been the industry standard for more than 30 years, with constant revisions to keep up with new approaches, regulations, and technologies. Get the guide here: https://bit.ly/3dAANXG

 

The application of Dynamic Vapour Sorption (DVS in food and food ingredients

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SMSLogo

Dynamic Vapour Sorption (DVS) has long been used for investigating the interaction of water vapour with foods and food ingredients. 
an Nice overview document give several examples of using DVS for food-related applications including: water activity, moisture content, moisture-induced phase transitions, water-vapour transmission rates, and flavour loss.Learn More

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Part 3 of 5 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft

 Written by Maurizio Della Pietra

There is little overlap with cleanroom monitoring and qualification and classification as seen in the image here:

Cleanroom Monitoring

The goal of cleanroom monitoring is to assess the potential contamination risk of the productThe key location focus of monitoring is at the manufacturing processes. The only connection with Cleanroom Qualification is that, as a secondary purpose, we also provide evidence of the performance of a cleanroom from the process point-of-view.

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Cleanliness classes for oils & fuels

Courtesy of Pamas

 To display particle counts in oil and fuel samples and even water-based hydraulic fluids, in a simplified and uniform way, results are often reported in cleanliness classes according to a specific reporting standard. In the following  article we discuss the most common and important international standards.

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IP PM FA – New test method for the determination of particulate contamination in diesel fuel

PAMAS40btext supplied by Pamas

In recent years there has been an increase of truck engine breakdowns reported in the South of the UK, the Benelux and Northern Germany. The injection systems of the truck engines had been heavily damaged by contaminated diesel fuel. Deliveries from a refinery in Eastern Europe was identified as the source of this contamination

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Part 2 of 6 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft

isob1The definition for Cleanroom Qualification is “The overall process to assess the level of compliance of a classified cleanroom with its intended use.” That is, classification is a part of qualification.

Qualification methodologies are identified in EU GMP Annex 15 and all verification must comply with the testing methodologies in ISO 14644-3:2019.

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Pamas software

softwarePamas wellknown for their extensive range of liquid particle counters compliment their instruments with various software packages. This article will explore the options avialable to Pamas customers.

Users familiar with the trusty S40 portable counter know the userfriendly download software . It is designed to simply download results from the instrumrent into a LIMS via a CSV file or into Excell.

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Cleanroom Classification

LasairIIIaWritten by Maurizio Della Pietra
Part 1 of 5 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft

Cleanroom Classification
Annex 1 provides essentially the same cleanroom classification definition as ISO 14644-1: 2015 which

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Which DVS (Dynamic Vapour Sorption) instrument is right for me?

When I look at any range of instruments all performing the same basic function I want to know what makes one model different from another. This is also true of the DVS series ( Intrinsic , Adventure, Resolution and Endeavour). In this short article I hope to make that a lot easier!

We know Dynamic Vapour Sorption is simply the measurement of the adsorption or de-sorption of a solvent on a solid material. Materials investigated using DVS includes Pharmaceutical powders, tablets, API’s and excipient materials), Food powders, processed food, biscuits, cement, ceramics, cosmetics, hair care, contact lenses, packaging materials: paper, plastics.

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Cleaning and Disinfection: the (newest) guidelines from Annex 1, rev 12

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The latest Annex 1 draft offers several updated expectations on cleaning, decontamination and disinfection. Definitions Cleaning (NEW)A process for removing contamination e.g. product residues and disinfectant residues. Decontamination The overall process of removal or reduction of any contaminants (chemical, waste, residue or microorganisms) from an area, object, or person. The method of decontamination (e.g. cleaning, […]

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How to Achieve Quality by Design (QbD) in a new Pharmaceutical Fill Line: Intro and Regulatory (Series Part 1 of 6)

courtesy of Maurizio dellapietra

In this blog series we will examine what a new fill line looks like with and without QbD implemented at the design phase. We will study each critical area of the fill line and the activities necessary to effectively bring the control features into effect. These examples come from real-world applications experienced by the Particle Measuring Systems’ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.

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Validation of Relative Humidity

Validation of humidity generation and measurement in gravimetric vapour sorption instrumentation is an important issue for the pharmaceutical and related industries. This application note sets out a standard DVS method for validation of relative humidity data using saturated salt solutions.

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Please measure the particle size

mastersizerpeople22Micron Scientific is a distributor of material characterisation instruments. We also offer an ad hoc contract analysis service for particle size. So we naturally receive many random calls from various people asking about testing their samples for particle size!

What are the most common questions we receive ?

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The new Spinning drop Video Tensiometer SVT 25

courtesy of Dataphysics

SVTThe SVT 25 is the new Spinning drop Video Tensiometer of the SVT series. With completely redesigned electrical components and many improvements it will continue the legacy of its successful predecessor SVT 20N.

Due to the high-performance camera with USB 3 interface the SVT 25 can resolve spinning drops with up to 2048 x 1088 pixel and hence offers five times the resolution of its predecessor. In Addition fast processes e.g. during oscillation experiments can be captured with up to 3250 frames/s.

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On Demand Webinar - Understanding ISO 14644-2:2015 Cleanroom Monitoring"

 

Are you sometimes confounded by all the regulatory standards for Pharma cleanrooms?! You're not alone! That's why we created the Webinar: "Understanding ISO Standards: 14644-2:2015 Cleanroom Monitoring".

 

If you have a couple minutes today, watch it here: https://lnkd.in/eaShw29

21 CFR Part 11 and Data Management for Data Integrity



21 CFR Part 11

21 CFR Part 11 and Data Management for Data Integrity

21 CFR Part 11 is the most widely used standard for appropriate data management. Part 11 applies to records in electronic format that are created, modified, maintained,
archived, retrieved or transmitted according to requirements set in FDA regulations. Electronic records/signatures that meet Part 11 requirements may be used in lieu of paper records.

The document is divided into three parts:

  1. Electronic Records
  2. Digital Signatures
  3. Audit Trail

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Surface Energy and Water Sorption Characterization of Fuel Cell Components

DVSAdventureThe research of fuel cells as alternative power generators is growing significantly. The humidity of the feed stream is vital to the performance of proton exchange membrane fuel cells. Also, the surface energies of fuel cell components is related to electro-osmotic drag, back diffusion of water, and water retention.

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New Handheld Particle Counter for Cleanroom Monitoring

Particle Measuring Systems releases the HandiLaz Mini II that measures to 0.2 μm.

For convenient and extensive point of use monitoring, the Particle Measuring Systems HandiLaz Mini II is a new low cost, handheld solution for cleanroom environmental research and troubleshooting needs.

The HandiLaz Mini II is uniquely suited for applications including Semiconductor component and equipment manufacturing, wafer fabrication, advanced materials production and research and testing laboratories. This compact unit offers an unlimited number of particulate size channels from 0.2-10 μm with 10 nm channel resolution. It utilizes a miniaturized, state of the art sensor with a simple touchscreen, single button operation and advanced on-screen analysis for getting physically close to and in detail with cleanroom environments.

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