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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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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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

Product Focus : RHEOLASER Master

rheolasermaster191141The RHEOLASER Master is an instrument that uses a technique called MS-DWS ( Multi-Speckle Diffusing Wave Spectroscopy) to probe the visco-elastic properties of a liquid or gel-like sample.

What is MS-DWS?

Multi-Speckle Diffusing Wave Spectroscopy is a technique that uses a ligh source to track the change in postion of tiny particles in a liquid or gel . From this movement a displacement curve over time is polotted which in turn in used to calculate elasticity , liquid/ solid like behaviour. gel point  and the viscosity index of samples. Learn More

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Turbiscan Tower has been recently upgraded

TSI Display and Design
As the TSI (Turbiscan Stability Index)  is more widely used by in both the industrial and academic fields, we decided to make it even more accessible by displaying it directly
on the LCD screen using the TSI colour scale. This means quick stability identification has never been easier!

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Latest pre-recorded webinars from Formulaction

Formulaction best known for their Turbiscan series fo instruments in South Africa now provides an extensive list of webinars on the application of their unique technlogies in industry.Learn more about what topics are avialable.

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Particle Measurement Systems expand their Knowledge Centre

Particle Measuring SystemsParticle Measurement Suystems best known in South Africa for their Lasair III air particle counters and active microbila samplers like the Minicapt Mobile recently expanded their knowldge centre with new Application notes, current webinars as well as on demand webinars. To learn more follow this link!

 

Laser diffraction - what does all these numbers mean ?

One of the most common set of questons we receive from our contract analysis customers and new Malvern Mastersizr uses is what does all these number on the Mastersizer report mean ? After years of answeing these questions I finally took the time to briefly explain it all ! Happy reading.

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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 immediatly is how easy the instrument is to use ! I'm so used to controling  an instrument via software and PC these days, it is almost a novilty!  It has a simple menue system that allows the user to operate the instrument directly ( ofcourse normal software control via PC is also possible).

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New autosampler from Pamas

AS3For laboratories with high sample quantities, PAMAS has designed the new PAMAS AS3 autosampling system. The system incorporates an automatic measuring process, so that several hundred samples can be analysed per day. 

The 3rd generation PAMAS auto sampler offers improved reliability, sample preparation, sample handling, flushing and sample dilution.

The PAMAS AS3 is designed to analyse several hundred samples per day, with unattended operation. The development of AS3is based on the feedback PAMAS received from users of existing PAMAS autosamplers and the requirements of potential customers. 

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Dynamic Vapour Sorption

Dynamic Vapor Sorption (DVS) is a gravimetric sorption technique that measures how quickly and how much
of a solvent is absorbed by a sample: such as a dry powder absorbing water. It does this by varying the vapor
concentration surrounding the sample and measuring the change in mass which this produces. Water vapor is most
commonly used, but it is also possible to use a wide range of organic solvents.

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Selecting the right particle counter for oil condition monitoring

 

PamasS40Series

We are frequently asked to quote for a liquid particle counter to test to ISO 4406(c) the particle cleanliness standard for hydraulic fluids. Pamas Gmbh is well regarded for their wide range of liquid particle counters. A quick browse through their webiste (and ours) shows there is the portable S40 and benchtop SBSS counters. So the natural question is which counter is best for the customer's application?

PamasSBSS

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Compressed Gases: An Important Component of an Environmental Monitoring Program in a Pharmaceutical Manufacturing Environment

The testing and monitoring of compressed air and other process gases such as gaseous and liquid nitrogen, oxygen, argon, and carbon dioxide that come into direct contact with pharmaceutical drugs during the manufacturing process is vital to assuring the quality and safety of these products. Read More

Speed of Sound Dynamic Vapor Sorption (DVS)

DVSAdventure“The only method that directly measure solvent vapor concentrations.”

Dynamic Vapor Sorption (DVS) is a gravimetric sorption technique that measures how quickly and how much of a solvent is absorbed by a sample. The latest advancement on DVS is its speed of sound sensor which increases the reliability and accuracy of DVS data by providing the only method for directly measuring solvent vapor concentrations.

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New ! Subscribe to our newsletter

We just launched the facility to subscribe to our custom newsletter. Depending on the areas of interest you will receive a free newsletter with the latest news in your selected area(s) of interest. Current topics include Particle size, shape, counting in air or liquid, rheology/ viscosity, product stability and zeta potential. You can update your preferences or unsubscribe at any time!

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New development from PAMAS the S50DP particle counter

PAMAS S50DP: The Particle Counter With Integrated Dilution System For Fluid Analysis

The PAMAS product range includes measuring instruments for long-term condition monitoring of liquids like hydraulic or lubricating oil or for contamination analysis of particulate matter in water, pharmaceutical suspensions and many other fluids.

The newly designed PAMAS S50DP has been specifically designed for fixed online measurement of dark fluids.
This online particle counter automatically dilutes dark sample fluids prior to measurement with its integrated dilution system , thus reducing the sample’s turbidity level. Fluid cleanliness (e.g. of oil, water or fuel) can be monitored through optical particle counting. An automatic particle counter detects and measures particulate contaminants in the fluid. 

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