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

PAMAS40bIn 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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Different Ways to Measure Viscosity

FluidicamRheo2The viscous properties of a liquid or amorphous solid are primarily determined by inter-particle
forces within the solution, including friction and attraction between molecules in the macrostructure.
These Van der Waals forces are critical facets of a sample’s resistance to deformation, or flow, which
defines the material’s viscosity.

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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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Product Focus: RHEOLASER Crystal

rheolasercrystalLooking at the technical description of the RHEOLASER Crystal it tells us it is a new thermal analysis instrument that can detect changes in the microstructure ( phase transition, melting or crystallisation ) of a liquid or solid sample. What does that actually mean in practise, and how is that information useful ? In this short article I will attempt to explain that.

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Turbiscan Classic, Lab , Tower or AGS - which model is best for me ?

turbiscanfam2by1Looking at the 4 models ( Turbiscan Classic 2/ Lab/ Tower/ AGS) it is easy to get confused and the natural question is to ask which model is best for me ? This article will attempt to give greater clarity on the differences between the models and the unique features each model offer.

All 4 models scan a liquid or paste sample for instability by detecting very small changes in sample concentration or size in tiny slices of the sample in a glass tube. This technology (invented by Formulaction back in the 1990's) offers an objective, reliable and above all quick way to decide if a product or formulation is stable or unstable. In most cases product stability is determined in 2 to 5 days at most. Multiple measurements is made over minutes to hours (depending on the sample).

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Product Focus: Wipfrag 3

WipFragsoftwareI receive regular enquiries about Wipware fragmentation analysis software Wipfrag 3.0 and which platform ( windows, apple IOS, Android (coming soon)) to use.

I will try to explain the diffrences in this short article. What I like about this technology is that allows the use ro get a size distribution of an good image just using software without the hassel (and potenital risk working at a rockpile) of sieving.

If you had quick look at the technology you will understand it a relatively simple process of capturing an image, loading it into the software and then fine tuning some threshold settings before generating a size distribution. Editing of the image is also possible to include or ignore particles etc….

The software on all the platforms looks exactly the same so where do the differences come in?

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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

Written by 

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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What is a colloidal dispersion and how to measure its stability?

adobestock 110jpegcolloidal dispersion is composed of solid, liquid or gas particles dispersed in a continuous phase (solid, liquid or gas). Strictly speaking, the term colloidal refers to particles with at least one dimension ranging from 1nm to 1µm. Most commonly encountered colloidal dispersions are solid-liquid (suspensions), liquid-liquid (emulsions), gas-liquid (foams), and solid-gas (aerosols) dispersions.

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Agrochemical Formulations

courtesy of Formulaction

Agrochemicals, such as fertilizers, and pesticides are big businesses. Since 2012total pesticide sales have remained relatively stable within the EU, with over 300M kg of pesticides alone being sold in 20162. The market has been moving towards growing demands of organic nutrition and higher concentration pesticides. Reducing our dependence on agrochemicals without posing risks to food security is challenging because pesticides, fertilizers and growth hormones all help to ensure improved and consistent crop yields.3

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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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VACCINES CHARACTERIZATION Latest pre-recorded webinar from Formulaction

Enhanced immunogenicity by controlling stability and redispersion properties. This webinar will focus on the recently published method to study the redispersion capabilities of vaccines. It explains how understanding the stability and dispersion properties of vaccines can help improve immunogenicity.

The case study will showcase our solution to characterize dispersions (stability, sedimentation, redispersion, packing…) based on Static Multiple Light Scattering technology - Turbiscan®. Learn More