The Rapid Mixer Granulator is a multi-purpose machine that can blend powders, granulate wet masses, and produce effervescent and melt pelletized products using mechanical agitation and shearing forces. Validation of the Rapid Mixer Granulator involves qualification of installation, operation, and performance to verify it can produce granules within specified parameters. Tests are conducted at different mixing speeds and times to ensure content uniformity and granule consistency meet acceptance criteria.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
$ CONTENTS $
#Introduction
#Objective of granulation
#Essential properties of granules
#Mechanism of bond formation
#Mechanism of granule formation
#Method of granulation
#Modern equipments in granulation technology
QBD Quality by design for Immediate release dosage formKushal Saha
Traditional approach of formulating a new drug product is an exhaustive task and involves a number of resources like man, money, time and experimental efforts. While, using this Quality by Design (QBD) approach one can get the pharmaceutical product of desired (best) quality with minimizing above resources as well as knowing the influence of one factor over the desired associated process. Hence aim of this study is the understanding of QBD approach to design product and manufacturing process to get desired pharmaceutical product. QBD follows the concepts of ICH guidelines (Q8, Q9 & Q10) which are essential for processing a pharmaceutical process. In this presentation we are going to focus upon QBD for immediate release dosage forms.
Qualification of Friability Test Apparatus.pptxGNIPST
Brief description of qualification of laboratory testing apparatus : Friability Test Apparatus.
share it with your friends also if they faced problem about this topic.
Thank you
Pharma Equipment - Manufacturer of Pharmaceutical Equipment and Furniturevinayak infosoft
Pharma equipments is ss pharmaceutical furniture and machinery manufacturer in india. Stainless steel specialists for clean room furniture & custom made equipments for pharmaceutical industries exporter and supplier from baroda, gujarat, india
$ CONTENTS $
#Introduction
#Objective of granulation
#Essential properties of granules
#Mechanism of bond formation
#Mechanism of granule formation
#Method of granulation
#Modern equipments in granulation technology
QBD Quality by design for Immediate release dosage formKushal Saha
Traditional approach of formulating a new drug product is an exhaustive task and involves a number of resources like man, money, time and experimental efforts. While, using this Quality by Design (QBD) approach one can get the pharmaceutical product of desired (best) quality with minimizing above resources as well as knowing the influence of one factor over the desired associated process. Hence aim of this study is the understanding of QBD approach to design product and manufacturing process to get desired pharmaceutical product. QBD follows the concepts of ICH guidelines (Q8, Q9 & Q10) which are essential for processing a pharmaceutical process. In this presentation we are going to focus upon QBD for immediate release dosage forms.
Qualification of Friability Test Apparatus.pptxGNIPST
Brief description of qualification of laboratory testing apparatus : Friability Test Apparatus.
share it with your friends also if they faced problem about this topic.
Thank you
Pharma Equipment - Manufacturer of Pharmaceutical Equipment and Furniturevinayak infosoft
Pharma equipments is ss pharmaceutical furniture and machinery manufacturer in india. Stainless steel specialists for clean room furniture & custom made equipments for pharmaceutical industries exporter and supplier from baroda, gujarat, india
Tablet Punching Machine, Rotary Tablet Press Machine, Dies and Puncheslouiesmith
Being one of the best manufacturers, suppliers and exporters of Tablet Punching Machine, Rotary Tablet Press Machine, Dies and Punches and Tablet Compression Machine Spares in India.
The most common method of drug delivery is oral dosage
form of which tablet and capsule are predominant.
Tablet is more accepted as compared to capsule due to
many reason such as cost, tamper resistance, ease of
handling, ease of identification and manufacturing efficiency.
Tablet compression process understanding is resulted in
development of formulation.
Recent advances in the design of tablet compression
equipment has conducted resulted in higher efficiency,
minimized tablet variation, greater flexibility.
It is the topic of Industrial pharmacy 2 from semester 7 of Bachelor of pharmacy.
It involved all information regarding Pharmaceuticals production scale up technique .role of managers, Engineer and scientists are explained properly .
ROLE OF MANAGER
1. Ensure a safe work environment for all pilot plant operations and compliance with all health and safety policies and procedures.
2.Provide technical leadership and operational oversight of Pilot Plant facility.
3.Partner with Process Development to optimize and implement new processes and technology at the pilot scale.
4.Train engineers and associates in the functional tasks necessary to successfully perform their duties.
5.Schedule activities of pilot plant personnel and ensure the tasks are completed in a timely manner.
6.Provide personnel career development, coaching, and feedback including performance management discussions with each direct report.
7.Train and oversee compliance with Quality Assurance policies and procedures that relate to the Pilot Plant.
8.Write and review standard operating procedures, batch records, process deviations reports, CAPAs, and change control requests.
Manage raw material receipt and release system.
9.Manage plant supplies and raw materials inventory.
Role of engineers:
1.Plant engineers oversee the electrical mechanical systems of a manufacturing plant, from installation to troubleshooting.
2. They are called upon to improve the plant's efficiency, upgrade to new technologies, repair equipment, increase production, and reduce manufacturing issues .
3.Try to process on a model of proposed plant before committing large sum of money on a production unit.
4.Examination of the formula to determine its ability to withstand batch scale & process modification.
5.Evaluation & Validation for process and equipment.
6.To identify the critical features of the process.
Guidelines for production & process controls.
7.To provide master manufacturing formula with instructions for manufacturing procedure.
8.To avoid the scale up problems.
Process of solid ,liquid dosage forms and their guidelines followed along with proper equipment study is provided and the major controls to maintain scale up consideration were mentioned.
Effective process validation contributes significantly to assuring drug quality. The basic
principle of quality assurance is that a drug should be produced that is fit for its intended use.
This principle incorporates the understanding that the following conditions exist:
• Quality, safety, and efficacy are designed or built into the product.
• Quality cannot be adequately assured merely by in-process and finished-product
inspection or testing
Process validation- This guidance incorporates principles and approaches that...Sanchit Dhankhar
This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.
It is the process of establishing, through documented evidence, a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality characteristics.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Raw material validation- process validationRavish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
2. The Rapid Mixer Granulator is a multi-purpose processor
equally suitable for high speed dispersion of dry powders,
aqueous or solvent granulations, and effervescent products
and melt pelletization.
3. Blending and wet massing is accomplished by high
mechanical agitation by an impeller and chopper.
Mixing, densification, and agglomeration of wetted
materials are achieved through shearing and
compaction forces exerted by the impeller.
4. The primary function of chopper is to cuts lumps into
smaller fragments and aids the bowl or sprayed onto
the powder to achieve a more homogeneous liquid
distribution.
5. VARIABLES :
PROCESS VARIABLES :
• Impeller rotation speed
• Chopper rotation speed
• Liquid flow rate
• Load of the mixer
• Liquid addition method
• Wet-massing time (subsequent of liquid addition
time)
6. PRODUCT VARIABLES :
Amount of liquid binder
Characteristics of liquid binder
Surface tension
Viscosity
Adhesiveness
Characteristics of the feed materials
Particle size and size distribution
Particle specific surface area
Solubility in the liquid binder
Wettability
Packing properties
12. Equipment installation site:
Equipment is installed in the location as specified.
Equipment is installed as per the supplier
instruction.
Packing debris are removed
As Built drawing is prepared and verified
13. Installation Qualification Procedure :
Test Equipment:
Spirit level For checking leveling of equipment
Multi meter For checking electrical supply
Molybdenum test kit To confirm material of
construction of the Stainless Steel 316 quality
14. Protocol Approval :
• Objective
• Critical Process control variables
• Test Program and Acceptance criteria
• Sampling points
• Qualification results
• Final Report
• Report Approval
15. OBJECTIVE:
To verify that the utility, environment, equipment and
support system produces the required output by integrating
procedures, personnel, systems and materials.
To verify the performance of the Rapid Mixer Granulator -
(RMG) for maximum occupancy capacity of 80%, minimum
occupancy capacity 30% and intermediate occupancy
capacity 55% based on 0.5 w/v bulk density, by adding
lactose and Ponceau 4R supra of 1% in RMG and estimate
the colour content uniformity in blend at different time
intervals.
To verify the performance of Rapid Mixer Granulator -
(RMG) for a specific size by granulating lactose with
HPMC solution and observe amperage and granules
consistency at different time intervals.
16. CRITICAL PROCESS CONTROL VARIABLES:
Process control variables of dry mixing, wet mixing
operations and measured parameters are identified as
follows
SS..
NNoo OOppeerraattiioonn ssttaaggee CCoonnttrrooll vvaarriiaabblleess MMeeaassuurreedd ppaarraammeetteerrss
11 DDrryy MMiixxiinngg LLooaadd ssiizzee
MMiixxiinngg ttiimmee
CCoonntteenntt uunniiffoorrmmiittyy
22 WWeett MMiixxiinngg IImmppeelllleerr ssppeeeedd,, cchhooppppeerr ssppeeeedd
GGrraannuullaattiioonn ttiimmee
AAmmoouunntt ooff ggrraannuullaattiioonn fflluuiidd
WWaatteerr ccoonntteenntt//LLOODD
GGrraannuulleess aappppeeaarraannccee
AAmmppeerraaggee //ttoorrqquuee
Performance of Rapid Mixer Granulator shall be verified at different
control variables such as load size, and mixing time.
17. Test program and acceptance criteria:
Objective:
To verify the performance of the Rapid Mixer
Granulator (150 lts) for maximum, minimum and
intermediate occupancy capacities and at different
mixing intervals.
Granulating performance for maximum capacity at
different control process parameters
18. Procedure (dry mixing):
Add Lactose and Ponceau 4R supra (sifted through 40#) into
Rapid Mixer Granulator and mix the material for a period of 20
minutes.
Collect samples in duplicate each equivalent to 2gms using unit
dose sampler from 5 different locations (shown in diagram and
transfer in to individual labeled glass vials.
Collect the samples at different time intervals of 5, 10, 15 and
20 minutes
Submit the samples for analysis of colour content. Analyse the
sample as per the analytical procedure. Record the results in
qualification result data sheets.
19. Sampling points in rapid mixer granulator
1 2
4
3
5
1.Top Left
2.Top Right
3.Middle
4.Bottom Front
5.Bottom Rear
20. Analysis procedure:
Sample preparation:
Weigh sample equivalent to 10 mg of Ponceau 4 R supra and
transfer into 200ml volumetric flask add 100ml of water and
sonicate for 5 minutes to dissolve completely, then dilute up to
the mark with water. Filter the solution and dilute 10ml of
filtrate to 50 ml with water.
Procedure:
Measure the absorbance at 506nm using UV spectrophotometer.
Calculate the % of colour content using following formula.
Acceptance Criteria:
Colour content (assay) of all samples should be in between 90
-110 %
The average of assay results at each interval should be in between
95 -105 %
Content uniformity of 5 samples RSD should not be more than 4%
21. Procedure (wet mixing):
Add specified quantity of HPMC in purified water and dissolve
completely.
Take specified quantity of Lactose monohydrate (sifted through
#40) into RMG, add above HPMC solution and granulate at
slow speed till the required consistent granules formed.
Record the time of granulation at different intervals (after
5minutes and every after 2minutes till granulation completed)
during granulation till appearance of granules the required
consistent granules formed.
Record appearance of granules and LOD of wet mass after
granulation completed.
Acceptance Criteria:
RMG should be capable of producing desired granules.
Amperage reading should be increased as granulation time
progresses.
Functioning of RMG should be in normal, safe and secure
condition.