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CILAS laser particle size distribution
CILAS laser - the automated auto sampler

MODELS \ range of measure
(direct access)

990 \ 0.2 – 500 µm
1090 \ 0.04 – 500 µm
1190 \ 0.04 – 2500 µm
Size Expert
Accessories :
- video camera,
- autosampler,
- alcohol regenerator,
- small volume unit.

ISO 13320
21 CFR-11

FRAUNHOFER / MIE
Reference powders



 

CILAS ANALYZERS COMPLIANCE TO THE to the ISO 13320 NORM


Introduction
As a general rule, instruments available on the market give quick results. However, the type of instrument used, the system accuracy, and the measurement protocol can affect the reproducibility of the measurement. The ISO 13320-part1 standard has been developed in order to provide the user with results that are independent of the instrument used.

The ISO 13320 Standard
The standard requires that the manufacturer calibrate the instrument using Certified Reference Materials (CRMs) of a known size distribution. The user must also verify operation of the instrument, both repeatability and accuracy, at regular time intervals using CRMs. The main requirements of the standard are the following :

Table 1: Summary of the main requirements of the ISO 13320 standard.

Requirement
Target values
Test Method
Repeatability
(6.4 in the standard)
Coefficient of variation
<3% for X50
<5% for X10 & X90
(below 10µm, these values
should be doubled)
The measurement is done
on at least 5 different samples from the same batch
Accuracy
(6.5 in the standard)
Maximum deviation from the certified range :
<3% for X50
<5% for X10 & X90
(below 10µm, these values
should be doubled)
Mean value over
3 independent
measurements

Note: X50 represents the median diameter in mm, which means 50% (by volume) of the particles are smaller than this diameter.

The ISO13320-1 norm can be downloaded on the ISO web site : click here

Available CRM
Fig 1. SEM Picture of Certified Glass Beads (from Whitehouse Scientific)Certified Reference Materials (CRMs) are made of spherical particles and the size distribution of these particles must retraced to a recognised size standard.

 

 

Fig 1. SEM Picture of Certified Glass Beads (from Whitehouse Scientific)

 

Measurement of the CRM with a CILAS Analyzers
Data collected using the CILAS 990L,1090L and 1190L instruments showed better repeatability and accuracy values than required in the ISO 13320 standard. Statistics from over 50 production instruments have shown a reproducibility of better than 1%.

Fig 3. Measurement of the 10-100 m m CRM with a CILAS 1090 system Fig 3. Measurement of the 10-100 m m CRM with a CILAS 1090 system

CILAS instruments are very accurate because of their unique short bench design. All CILAS systems use a permanently aligned optical bench without any moving parts to provide superior repeatability.

The ISO 13320 standard provides the industrial laboratory an effective method for instrument selection. Laboratories who use the standard can guarantee the accuracy and reproducibility of their measurements throughout the entire life of the instrument.

 
What’s New
 

sharpe analysing

Come and see our particle size analyzer and shape solutions at the following trade shows : (for more details, click on the shows).

EUROPE

2013 PharmaSc
2 - 4 September
Edinburgh
UK
http://www.ukpharmsci.org/Default.asp

LABOREXPO
Booth 19
25 - 26 September
Praha
CZECH REPUBLIC
http://www.laborexpo.cz/?lang=en

Trade Fair Brno
Booth 30
7 - 11 October
Brno
CZECH REPUBLIC
http://www.bvv.cz/en/msv/

6th International Forum of Laboratory Complex
15 - 17 October
Kiev
UKRAINE
http://www.labcomplex.com/en/index.php

AMERICAS

Southeast Catalyst Show
September
Asheville
USA

American Association of Pharmaceutical Scientists Show
10 - 14 November
San Antonio
USA
http://www.aaps.org/annualmeeting/

ASIA

JASIS 2013
5 - 7 September
Chiba-City
JAPAN
http://www.jasis.jp/2012/english/next/index.html

Taipei International Instruments Trade Show
3 - 6 October
Taipei
TAIWAN

ChemTech 2014
January
Mumbai
INDIA

particle sharpe
granulometre