SEMINAR ON CHEMICAL AND BIOLOGICAL EVALUATION

SUBMITTED BY, C.ULAGANATHAN, DEPT. PT. OF PHARMACEUTICS, BHARATHI COLLEGE OF PHARMACY.

SUBMITTED TO, Dr. S RAJA, DEPT. PT. OF PHARMACEUTICS, BHARATHI COLLEGE OF PHARMACY.

APPLICATION OF COMPUTERS IN QUALITY CONTROL LAB

CONTENTS: Parts of computer Advantage& Disadvantage. Active application. Passive application. Other application.

COMPUTER is a

C=Commonly O=Oriented M=Machine P= Particularly U=Used for T=Technology E=Education and R=Research

Various parts of typical computer:

A computer consists of various hardware components that work together with software to perform various activities.
COMPUTER INPUT DEVICES Ex:keyboard mouse etc OUTPUT DEVICES Ex:monitor, printer, speaker Typical computer components System Unit

CPU AND MEMORY

Storage Devices Ex. Floppy, CD, DVD..

A COMPUTER IS AN ELECTRONIC DEVICE WHICH PERFORMS OPERATION SUCH AS:

COMPUTER TASKS Accept the data Process or manipulate the data output the result in the form that suitable for Human understanding Stores the input data results..

 All these activities are performed based on the instruction that are stored in the memory of the computer.  All these tasks are performed at tremendous speed & very high accuracy.

ADVANTAGE:
    Easy to use Simple & accurate Very fast Comparison

DISADVANTAGE:
    It is very expensive It fully depends on electricity Expertization required Some can lead to damage data

Application with analytical instrument:

ACTIVE APPLICATION PASSIVE APPLICATION

ACTIVE APPLICATION
In this computer control the interaction with an instrument . The output from computer control sequence of steps required for the operation of the instrument. FOR EXAMPLE:
IN spectroscopy determination the computer may be,

 Choose a proper source & Active the source.

 Adjusting the intensity of light& Correcting the base line  Allow the radiation to pass through the blank and sample& control the monochromatic so choose proper wavelength.  Adjust the detector response and record the intensity level. in addition computer may be programmed to vary the experimental condition. So quality of the subsequent data is improved.

Example:2


Adjustment of slit width & wavelength

 The temperature of chromatograpic coloumn  The potentiol applied to an electrode  The rate of addition of reagent  The time at which integration peak is to start  Initiate of data collction of a GC-MS instrument

Computer control can be relatively simple as can be in this following example:

Determination of concentration of element by atomic emission involves measurement of the heights of emision peak, which are found at wave length that are chararectristic of each element. In above cause computer can make,
  A monochromater to rapidly shift a range of wave length until a peak is detected. The rate of shift is then slowed to determine the exact wavelength at which the height of peak occurs.

 Intensity measurement is made at this point until an average is obtained that gives a suitable signal to noise ratio.  The computer then causes the instrument to repeat the experiment for each peak of interest in the spectrum.  Finally the computer calculates and print out the concentration of element Present, because of its great speed. The computer can after control variables more efficiently than human operation.

PASSIVE APPLICATION:
 In this, computer does not control the interaction with an instrument, but used for data handling, processing, file searching or display.

 Data processing by computer may involve relatively simple mathematical operation such as: o Calculating of concentration, data storing. o Sequence analysis, statistical analysis. o More complex calculation may involve. o Solving of non-linear equation. o Performing Fourier transformation.(In, NMR, MASS Spectrometer). o Determine of unknown concentration using calibration curve.

DATA STORAGE:
 This function is very very useful especially in storing the results of GLCMS Experiment.

 The GLC separates components from the mixture and the mass spectrometer identifies fragments of thee individual component based on their mass.

GLC_MS may produce data for many spectra in a few minutes, each spectrum being made up of few to hundreds of peaks & conversion of these data into an interpretable form is often impossible.

 Thus data are often stored in digital form for subsequent processing and

presentation in graphical form, this function is done by computer.

The HPLC-MS or HPLC-NMR data can also be handles in a similar way as described for GLC-Ms various experiments in 2-DNMR are possible just because of the use of computer because they involve complex calculation.

OTHER APPLICATIONS:
  The connectivity through computer helps different department of institutes to co-ordinate in a project. Entering of goods received numbers like product name, source, batch number and code numbers sampled by with date.

Taking of labels:
Under test. Passed. Rejected. Sample for analysis Reserve sample.

To prepare test data sheet:

It should contain a test mentioned in a specification like description, identification, LOD, LOQ, Assay, residual solves.

To preparing of specifications like good analytical methods ,sop, chemical usage log, Working std usage log, instrumental usage log.

Connectivity through internet to a data base library helps in faster accession of information from any part of the world.

SALVAGING OF RETURNED GOODS AND REPROCESSING.

CONTENTS: Definition Advantage Salvaging operation. Reprocessing & Recoveries.

DEFINITION OF SALVAGING

Salvaging of returned goods may be defined as those goods which are to be disposed without causing to any harm to the living organism Any rejection lying in the factory to obtained useful parts from them are called salvaging of returned goods ADVANTAGE: It is the savings for advantageous use of disposal of pharmacy companies property which is no longer economically useful to its user in the present situation. salvaging provides means of increasing cash income, reducing the cost of the companies product or service and conserving raw material.

SALVAGE OPERATION:
 Proper collection of all material preferably at one place.

 Storing them as systematically as other materials.  Storing in terms of quantity, size or specification so as to obtained maximum sale value.  Reclamation of scrape material.  Restoring material to functional condition and transferring them to stores.  Selling the material immediately to buyer  Taking precaution for manufacturing waste products.  Procedure for salvaging of returned goods:  The finished goods which are sent to the market for sales may be returned back to the stores

RETURNED GOODS:
 The reason for the returned goods may include quality of the product packing Problems, contamination of goods.

After receiving the returned goods to store, first we have to collect data regarding date of receiving the goods, amount of the goods, types of the goods, and due to which caution they are sent from the market.

  

We would also note about the stock exchange market of the product.

The returned goods are tested for quality control test once again and compare with That of the standard limits. If the goods have limited variations or if they can corrected.

 If the returned goods are much variation when compared to the standard limits, They should be disposed in away that they are converted to harmless product Which do not interfere the environment cycle.  Waste management legislation, Environment commities are formed on july2000. This legislation made rules Reduce the waste.

 These committees made rules and regulations to eliminate waste before it is Produced reduce its quantity and toxicity.  Waste minimization can be used to reduce global waste problem.  The waste material is the biggest and major issue in the govt and community. If we minimize waste by avoiding and reducing waste material we can control up to 50 percent or more.

There are three problem which are invoved in the reduction of waste material.
THEY ARE :

Reduce Reuse Recycle.

REDUSE:

waste should be reduced . The by - products or end products should be used in the other manufacturing process and should be reduce the production of waste product during manufacturing of the product.

REUSE:

The substances or the products which can be reused can be manufactured and reduce the waste.

RECYCLE:

 This process involves the converting the waste into useable products.  There are different types of material like GLASS, PLASTIC, ALUMINIUM which are used for packing the manufactured goods, Eg; for glass- multi filling bottles and single filling bottles

REPROCESSING AND RECOVERIES

 Where reprocessing is necessary, written procedures shell be established and approved by the QA department that shell specify the conditions and limitation of repeating chemical reactions, such reprocessing is validated.  If the product has to be processed the procedures shall be authorized and recorded. An investigation shall be carried out into the causes necessitating reprocessing and appropriate corrective measures shall be taken for prevention of recurrence and then these are subjected to stability evaluation.  Recovery of product and control record by incorporating in subsequent batches of the product.