▶ Brief instruction:

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   The raw material inspection is a precondition to guarantee the quality of  pharmaceutical  drugs. It is the primary link of quality control. Therefore when GMP and  FDA audit the pharmaceutical companies, raw material inspection process is a very  important section. The Specific Optical Rotation of the raw materials, such as sugars,  acids, oils and tartaric acid are required to be measured.

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  Sugars including sucrose, lactose, maltose, sweeteners, etc. It is a typical optical active  substance and can be measured by the polarimeter to verify the purity and content of raw  sugar. The sample in this case is sucrose.

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  Insmark Digital Polarimeter (FD series) mainly used in food and pharmaceutical industry. This instrument has special designed software which meets the U.S. Federal standard 21CFR requirements. Through a series of measures such as user rights management, audit trail, electronic records, electronic signatures, data security transmission software to ensure that the measurement data are true and reliable.

▶ Operation process:

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➣ Sample from: Heilongjiang XX pharmacy company

➣ Instrument: IP-digiFD2 Polarimeter(FD: Food and Drug system), thermostat system(Peltier)

➣ Laboratory: with air-conditioner, humidity control device;

➣ Room temperature: 21.0℃, humidity: 38%

➣ This instrument is new and will be set up in the customer’s laboratory. An engineer from Insmark will finish this instrument installation, give a 3Q test, train      the customer  to operate the instrument. All the samples are from the customer. 

▶ Operation process：

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1)  The instrument installation will be done by the Insmark Engineer. Performing IQ test, install the digi_link_FD data output software on the customer computer

2)  Training the laboratory administrator (Admin.), and set up the software according to the specific requirements of the laboratory

3)  Complete the OQ verification, verify the accuracy and repeatability of the instrument with the standard quartz tube, and verify the accuracy of the                   thermometer

4)  Train the operator to take a actual sample measurement.

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a.  Sample preparation: weighing sample amount 10 grams with a weighing paper. Transfer the sample to a 100ml volumetric flask. Add a little DI water to            dissolve it, mix it well, add the DI water to the flask mark.
b.  Instrument setting: 

     IP-digiFD2 Polarimeter has FD system. The measurement method must be pre-set by  the Administer. This instrument also has thermostat control                           system(Peltier). The  Admin can  set the measurement temperature at 20.0℃ in the measurement method. This will ensure the measurement accuracy.

c.    Operator log in his own account to take the sample measurement.

    ➢   Operator can select an corresponding method. 

    ➢   Add DI water to the 1dm thermostat sample tube to ‘zero’ the instrument. 
    ➢   Add sample to the same sample tube, take the sample measurement.
    ➢   The operator signed and submitted his measurement result.

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d.  The admin approve the measurement data. Transfer the data to PC in PDF format,  this will ensure that the data is true and reliable without tampering.

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e.  After all the training sections, the administrator sign the documents.

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  3. Conclusion: 

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  The customer is fully satisfied with the FD Polarimeter. This instrument  operation system meets the requirements of 21CFR and GMP. This will help  the QC department in improving the quality of data integrity  management, farther more  in product quality control management.

 

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*S.O.R.: Specific Optical Rotation

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