Thursday, December 13, 2012

Gas Chromatography

Gas Chromatography

Gas chromatography (GC) is an analytical technique for separating compounds based primarily on their volatilities. Gas chromatography provides both qualitative and quantitative information for individual compounds present in a sample. Compounds move through a GC column as gases, either because the compounds are normally gases or they can be heated and vaporized into a gaseous state. The compounds partition between a stationary phase, which can be either solid or liquid, and a mobile phase (gas). The differential partitioning into the stationary phase allows the compounds to be separated in time and space.
Fig- Gas Chromatography 

Fig- Flow chat of Gas Chromatography


HUMAN RESOURCE DEPARTMENT

HUMAN RESOURCE DEPARTMENT
Human Resource Management (HRM) is the function within an organization that focuses on recruitment of, management of, and providing direction for the people who work in the organization. Human Resource Management is the organizational function that deals with issues related to people such as compensation, hiring, performance management, organization development, safety, wellness, benefits, employee motivation, communication, administration, and training.
Human resources are a term with which many organizations describe the combination of traditionally administrative personnel functions with performance, employee relations and resource planning. The objective of Human Resources is to maximize the return on investment from the organization's human capital and minimize financial risk.

Features of HR:  
It includes:
  • Organizational management
  • Personnel administration
  • Personnel management
  • Manpower management
  • Industrial management
Functions of Human Resources Department

The Human Resources Department deals with the following affairs to achieve the objectives of the organization as well as the goal of department-
¨     Recruitment, Selection and placement of the employees
Promotion, transfer, demotion & disciplinary action of the employees
¨     Leave of the employees
¨     Lunch for the officers and stuff
¨     Maintenance of personnel records
¨     Procurement, washing & repairing the uniforms
¨     Arranging medical facilities for the employees
¨     Induction of newly appointed employees
¨     Govt. liaison (related with ministry of labor, local authority, Inspector of facilities.


The main function of this department are-

¨     Selection of right person at right position
¨     Training and development
¨     Wage and salary administration
¨     Employee welfare services
¨     Environment, health & safety (EHS)
¨     Disciplining the employees

In a single word this department controls almost all the sections in Square Pharmaceuticals ltd.

Discussion on the plant’s activity and introduction to all Departmental Heads

Duties and responsibilities of Shift in-charge
F Ensure house keeping and cleanliness in the section.
F Supervise shift wise sectional activities
F Effective utilization of machine hours.
F Shift wise man power distribution.
F Weekly and monthly production monitoring.
F Supervise export and institutional order processing.

Duties and responsibilities of Executive

F Planning of production of potent, safe, effective and stable medicines by maintaining
F the WHO cGMP procedure. 
F Organizing and controlling of routine activity in the factory.
F Monitoring and reviewing of present production target.
F Distribution of work on the basis of machine availability and production priority and
F check the attendance of the worker.
F Proper planning and implementation of routine production activity.
F Designing and the implementation of in-process checks at different steps of manufacturing

Functions of Foreman

·        Supervise maintenance of machinery and equipment.
·        Maintain proper documentation of all activities rotated to production.
·        Allocate manpowered as per job requirement.
·        Maintain housekeeping and cleanliness.
·        Place requisition for packaging operation.


Functions of Worker

·        Manufacture of the product as per formulation and manufacturing instruction.
·        Apply the in-process control measures as per required by the product according to the instruction procedure.
·        Perform packaging of product as per packaging instruction.
Maintain housekeeping and sanitation of the production floor

Wednesday, December 12, 2012

Tablet Coating


Tablet coating
Tablet coating may define as masks tastes/odors/colors protects drug modify & control drug release identification/brand recognition/looks better cons: expense bioavailability tablet quality requirements.
In other word, tablet coating is define as control taste control release enteric coating - ph dependent release prevent degradation in stomach protect stomach from irritant drugs target delivery to intestine should never be crushed controlled dissolution.
Classification of Coating:
1.      Suger Coating
2.      Enteric Coating
3.      Film Coating :-
a)      Aqueous Coating
b)      Non-aqueous Coating
Purpose of coating:
Many solid pharmaceutical dosage mediums are produced with coatings, either on the external surface of tablets, or on materials dispensed within gelatin capsules. Coating serves a number of purposes:
Ø  Protects the tablet (or the capsule contents) from stomach acids.
Ø  Protects the stomach lining from aggressive drugs such as enteric coated aspirin.
Ø  Provides a delayed release of the medication.
Ø  To mask the unpleasant taste, odor or color of the drug.
Ø  Helps maintain the shape of the tablet.
Ideally, the tablet should release the material gradually and the drug should be available for digestion beyond the stomach. The coating can be specially formulated to regulate how fast the tablet dissolves and where the active drugs are to be absorbed into the body after ingestion.
Many factors can affect the end-use properties of pharmaceutical tablets:
  • ·         Chemical composition
  • ·         Coating process
  • ·         Drying time
  • ·         Storage and environmental monitoring
 Pre-dispensing check list for coating materials:
1.      Room cleaning certificate
2.      Equipment cleaning certificate
3.      Formulation Order (FO)
4.      Room temperature
5.      Accessories

Formulation of coating:
Æ  Polymeric materials
Æ  Solvent
Æ  Titanium dioxide
Æ  Color
Æ  Flavor
Æ  Preservative
Æ  Plasticizer

Coating Process Design & Control:

    Tablet coating takes place in a controlled atmosphere inside a perforated rotating drum. Angled baffles fitted into the drum and air flows inside the drum provide means of mixing the tablet bed. As a result, the tablets are lifted and turned from the sides into the centre of the drum, exposing each tablet surface to an even amount of deposited/sprayed coating.


   The liquid spray coating is then dried onto the tablets by heated air drawn through the tablet bed from an inlet fan. The air flow is regulated for temperature and volume to provide controlled drying and extracting rates, and at the same time, maintaining the drum pressure slightly negative relative to the room in order to provide a completely isolated process atmosphere for the operator.
    Tablet coating equipment may include spray guns, coating pan, polishing pans, solution tanks, blenders and mixers, homogenizers, mills, peristaltic pumps, fans, steam jackets, exhaust and heating pipes, scales and filters. Tablet coating processes may include sugar coating (any mixtures of purified water, cellulose derivatives, polyvinyl, gums and sugar) or film coating (purified water, cellulose derivatives).
   The coating process is usually a batch driven task consisting of the following phases:
·         Batch identification and Recipe selection (film or sugar coating)
·         Loading/Dispensing (accurate dosing of all required raw materials)
·         Warming
·         Spraying (application and rolling are carried out simultaneously)
·         Drying
·         Cooling
·         Unloading
   A control system must therefore provide flexibility in the way in which accurate and repeatable control of the coating environment is achieved and will include the following features:
·         Precise loop control with set point profile programming
·         Recipe Management System for easy parameterization
·         Sequential control for complex control strategies
·         Secure collection of on-line data from the coating system for
·         analysis and evidence
·          
·         Local operator display with clear graphics and controlled access to parameters

Production of Tablet in Pharmaceutical Industry


Tablet
Tablet is the most used dosage form in the world. Because of –
                                     I.            High stability
                                  II.            Easy to transport
                               III.            Least expensive
                               IV.            Large scale production
                                  V.            Product indication is very simple
                               VI.            Control release of drug
                            VII.            Reliable therapy
                         VIII.            Conventional route for administration

Tablets are the solid preparations each containing a single dose of one or more active ingredients and obtained by compressing uniform volume of particles.
According to British Pharmacopoeia, “Tablets are solid dosage forms circular in shape with either flat or convex faces and prepared by the compression or compaction of suitably prepared medicament by means the tablet machine”.
Tablets are intended for oral administration. Some are swallowed whole, some after being chewed; some are dissolved or dispersed in water before being administered and some are retained in the mouth where the active ingredient is liberated.
Being the most common, convenient and inexpensive dosage form, tablet formulation and design is the most important consideration in solid dosage form production in the pharmaceuticals, which may be described as the process whereby the formulator ensures that the correct amount of drug in the right form is delivered at or over the proper time at the proper rate and in the desired location, while having its chemical integrity protected to that point.
In tablet manufacturing, facilities for dry granulation, wet granulation and direct compression are available. For all solid and semisolid section all the ingredients are dispensed centrally by “Pharmacy” against FO. Penicillin tablets are manufactured using dry granulation using separate facilities. Most of the tablets are done using wet granulation and fewer by direct compression.
In tablet manufacturing, facilities for dry granulation, wet granulation and direct compression are available. For all solid and semisolid section all the ingredients are dispensed centrally by “Pharmacy” against FO. Penicillin tablets are manufactured using dry granulation using separate facilities. Most of the tablets are done using wet granulation and fewer by direct compression.
Unit of tablet section:
Ä  Dispensing Unit
Ä  Granulation Unit
Ä  Compression Unit
Ä  Coating Unit
Wet granulation
Wet granulation is widely used technique. Dry granulation is used for the preparation of antibiotic table.
Flow chart for Wet Granulation
 Preparation of Starch Paste:
1.      Distilled water is added to make a suspension.
2.      Boil distill water by passing steam in a separate container (1000C).
3.      Add the hot water to the suspension and is stirred vigorously.
4.      The paste is allowed to cool down to 400C and is applied to the mix.
Flow chart for Dry Granulation

Flow chart for Direct Compression:





 Flow Chart of Tablet Manufacturing




Fig: Tablet manufacturing procedure


A formulation order consists of the following things
1.      Product name
2.      Product description
3.      Product code
4.      Lot number
5.      FO number
6.      FO effective date
7.      Cost centre
8.      Pharmacy weighting & date
9.      Pharmacy certification
10.  Component grade
11.  Batch in Grams
a)      Standard
b)      Dispensing
12.  Actual potency
13.  Actual batch activity in GMs
14.  Validation up to
This FO prepared & checked by PD; Approved by-
ü  Q.A. Manager
ü  Production Manager
ü  Plant Manager