Quality Control Test For Capsule

Raw Material Testing:

GELATIN
            BLOOM
            VISCOSITY
            MOISTURE
            PH
            ISO IONIC POINT,PH
            PARTICLE SIZE
            SO2 (PPM MAX)
            H2O2
            CLARITY
            MICROBIAL STANDARDS
Water
Fill material – powder
                      Semi solid  
                      Liquids-suspension, emulsion, solutions 

I.P.Q.C:
DURING FILLING

WEIGHT VARIATION TEST
MOISTURE CONTENT
LOCK LENGTH

 Final Product Q.C :
*    PHARMACOPIEAL STANDARDS
            UNIFORMITY OF MASS
            UNIFORMITY OF CONTENT
            DISINTEGRATION TEST
            DISSOLUTION TEST
            MICROBIAL TEST
*    INDUSTRIAL STANDARDS
            DIMENSION
            CAPSULE SHAPE   
            SOLUBILITY            ODOUR

 EQUIPMENT VALIDATION:
EQUIPMENT
COMPONENT
INSTRUMENTED
PARAMETER MEASURED
ZANASI LZ64
PISTON
COMPRESSION FORCE
RENTENTION FORCE
EJECTION FORCE
DRAG FORCE
H & K GKF330
TAMPING PINS
TAMPING FORCE
MACOFOR 13/2
DOSATOR
POWDER BED HOLDER
PISTON SHAFT
PISTON TIP
DOSATOR MOVEMENT
PISTON MOVEMENT
COMPRESSION FORCE
EJECTION FORCE
RADIAL FORCE AT TUBE TIP
mG2
DOSATOR PISTON
PUNCHES
TAMPING PINS
UPPER PUNCH MOVEMENT
LOWER PUNCH MOVEMENT
UPPER PUNCH FORCE
LOWER PUNCH FORCE
PIN MOVEMENT
COMPRESSION FORCE

Comments

Post a Comment

Popular posts from this blog

PLANT LAYOUT FOR CAPSULE MANUFACTURING DEPARTMENT & MANUFACTURING PROCESS

Image
PLANT LAYOUT  FOR CAPSULE MANUFACTURING DEPARTMENT: ENVIRONMENT CONDITION FOR CAPSULE FILLING AREA Humidity:          Not more than 35% RH Temperature:    Not more than 25% Area of each room, position of equipments, washing, drying, and sanitary facilities must be in accordance with GMP. MANUFACTURING PROCESS: CHEMCAPS Limited is an India based young and dynamic organization engaged in the manufacture and export of 'empty hard gelatin capsules' under the brand name of 'Chemlock' for discerning customers around the globe. COMPOSITION                                     Gelatin                                     Water                                     Colorants                                     Opecifier (TiO2 Dyes and Other)                                     Preservative MANUFACTURING OF HGC SHELL: SFR-901 FULLY AUTOMATIC CAPSULE MACHINE: FEATURES OF SFR-901 Ø   The Safrroys SFR-901 mod
Keep reading

ANTIOXIDANTS: In Pharmaceutical Formulation

Image
Introduction: Chemically they are reducing agents. They oxidize themselves and prevent oxidation of API. A substance that inhibits oxidation is called antioxidants. The effectiveness of antioxidant can depend on the concentration used and pH of solution. Examples:  Ascorbic acid,  butylated hydroxy anisole (BHA),  butylated hydroxyl toluene (BHT) Oxidation is a chemical reaction involving the loss of electrons or an increase in oxidation state. Oxidation reactions can produce free radicals. In turn, these radicals can start chain reactions. When the chain reaction occurs in a cell, it can cause damage or death to the cell. Antioxidants terminate these chain reactions by removing free radical intermediates, and inhibit other oxidation reactions. The following are some of the qualities of an ideal anti-oxidant: It should be readily soluble or dispersible in the medium. It should be effective in low concentration. It should be non-toxic. It should be non-irrita
Keep reading

3. Development of working hypothesis:

Image
After extensive literature survey, researcher should state in clear terms the working hypothesis or hypotheses. Working hypothesis is tentative assumption made in order to draw out and test its logical or empirical consequences. As such the manner in which research hypotheses are developed is particularly important since they provide the focal point for research. They also affect the manner in which tests must be conducted in the analysis of data and indirectly the quality of data which is required for the analysis. In most types of research, the development of working hypothesis plays an important role. Hypothesis should be very specific and limited to the piece of research in hand because it has to be tested. The role of the hypothesis is to guide the researcher by delimiting the area of research and to keep him on the right track. It sharpens his thinking and focuses attention on the more important facets of the problem. It also indicates the type of data required
Keep reading

Facebook Page

Knowledge of Pharma