Fluidized bed drying is the optimal method for controlled, gentle and even drying of wet solids. The intensive heat/mass exchange of the fluidized bed product. VALIDATION OF FLUIDIZED BED PROCESSOR (MINI GLATT), Rathore Garvendra S, Gaur Ajay, Rathore Shashi, Shekhawat Madhu and Gupta Roop N. The Wurster HS processing insert, patented by Glatt in , provides significant improvements over conventional Wurster coating technologies through.
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Validation is a concept that has been evolving continuously since its formal appearance in the United States in An equipment validation program can be described in four sequential phases: Prequalification, Bedd, Process qualification and Process validation. Prequalification includes vendor specification, design and operation checkout. Qualification includes installation and operational check out including design qualification, installation qualification, operational qualification, performance qualification and maintenance qualification.
A fluid bed system brings powdery or grained substances bulk material in a floating condition, with the carrying air flow enabled to exchange heat and substances with the floating material.
Fluidizes bed processor Mini Glatta component laboratory device uses the above principle and the equipment is designed to perform bdd, granulation and coating fkuid processafter a few changes over the machine tower for the relevant.
The validation of Mini Glatt with respect to various functions and parameters was conducted and the study revealed that glaft the functions and parameters were complying with specifications set and required. All Published work is licensed under a Creative Commons Attribution 4. Related article at PubmedScholar Google. Validation is documented evidence that provides a high degree of assurance that a specific process will consistently processor a product that meets its predetermined specifications and quality attribute .
The concept of validation has expanded through the years to encompass a wide range of activities from analytical methods used for proocessor quality control of drug substances and drug products, to equipments, facilities and process for the manufacture of drug substances and drug products to computerized systems for clinical trials, labeling or process control. Validation studies are essential part of Good Manufacturing Practice GMP and should be conducted in according with predefined protocols.
A written report summarizing results and conclusions should be recorded, prepared and stored .
Validation should thus be considered in the following situations : Process and equipment which have been altered to suit changing priorities; and? Process where the end-product test is poor and an unreliable procsesor of product quality.
The key elements of a validation programme are clearly defined and documented in a validation master plan VMP .
It should define details of and time scale for the validation work to be performed. Validation of pharmaceutical process equipment involves the following four sequential phases : Process validation is applicable to the manufacture of pharmaceutical dosage forms. It covers the initial validation of new processes, subsequent validation of modified processes rpocessor re-validation. Maintenance qualification is used to describe and document regular maintenance and repairs.
Glatt India Pharma Engineering Pvt.
Fluid Bed Wurster HS Coating Systems from Glatt Air Techniques
Ahmedabad and it complies with the scope of supply. URS of Mini Glatt fluidizes bed processor was prepared by a coordinated approach among production, quality assurance, and engineering department of Astron Research Ltd.
Ahmedabad, considering all the GMP requirements the machine has to fulfil. The protocol is industry tool used to document the qualification process but it can take any form. Major elements of qualification protocol are given in Fig. It consists of compressed air supply, filtering and regulating unit, air flow meter, heating chamber consisting of heating element, process air control valve.
It consists of lower plenum where the bottom spray gun fixing port is provided, product container to hold powders, expansion chamber with spray port, acrylic windows to view the process, filter housing to view the process and filter housing to fix product retaining cartridge filter.
Consists of peristaltic spray pump and vluid gun with atomizing air connection. Indication and control elements: The compliance of the design of Mini Glatt bex bed processor with GMP was demonstrated and documented.
The design qualification complies with the requirements and was accepted. IQ includes installation of bd, piping, services, instrumentation checked to current engineering drawings and specifications, collection and collation of supplier operating and working instructions, calibration requirement and verification of materials of construction.
All the above parameters were checked and installation qualification complies with the requirements and was accepted. Much of the qualification testing entails working with placebo batches. The completion of operational qualification allows finalisation of calibration, operating and cleaning procedures, operative training and preventative maintenance requirements.
The operational qualification complies with the requirements and was accepted. This verifies that the system glatr repeatable and is consistently producing a quality product . Sometimes termed process validationthis is the stage at which equipment is used in earnest. There are two basic approaches to the validation of the process itself apart from the qualification of equipment used in production, the calibration of control and measurement instruments, the evaluation of environmental factors, etc.
These are the experimental approach and the approach based on the analysis of historical lrocessor. The experimental approach, which is applicable to both prospective and concurrent validation, may involve : Control of process parameters mostly physical. Process controls include raw materials inspection, in-process controls and targets for final product.
VALIDATION OF FLUIDIZED BED PROCESSOR (MINI GLATT) | Insight Medical Publishing
The purpose is to monitor the on-line and off-line performance of the manufacturing process and then validate it. Even after the manufacturing process is validated, current good manufacturing practice also requires that a well-written procedure for process controls fliid established to monitor its performance .
Prior to the equipment being used on routine production, representatives from Production, Engineering and Quality Assurance approve the validation documentation.
As a result, this helps ensure that the equipment can be continuously operated to avoid downtime. Maintenance qualification covers all necessary measures entailing cleaning, maintenance and repair.
This work is documented in a service logbook. All the samples analysed complies with the requirements and are with in acceptable limits. No deviation was observed at any stage of qualification. The study revealed that all the functions and parameters were complying with specifications set and required.
Fluidized bed drying
All acceptance criteria set are meeting the requirements, hence the equipment is qualified. Committee on Specifications for Pharmaceutical Preparations. Good Manufacturing Practices for Pharmaceutical Products. World Health Organization,pp Tropical Journal of Pharmaceutical Research, December ; 1 2: The Validation of Cleaning Procedures. Pharm Techno, ; 8 5: Process Validation of a Year retrospective study of solid dosage forms.
Drug Dev Ind Pharm, ; 22 1: Drug Inf J, ; Select your language of interest to view the total content in your interested language. Can’t read the procwssor Validation is a concept that has been evolving continuously since its formal appearance in the United States in . Validation of pharmaceutical process equipment involves the following four sequential phases :.
User requirement specifications are the basic document that covers all the needs of the manufacturing department. The qualification protocol is the center of gravity of validation documentation process. It is the first element of the validation of new facilities, systems or equipment.
Installation qualification is performed on new or modified facilities, systems and equipment. The operational qualification describes all aspects of the testing of the equipment in detail.
Performance qualification represents the actual studies conducted to show that all systems, subsystems or unit operations of a manufacturing process perform as intended. The experimental approach, which is applicable to both prospective and concurrent validation, may involve :.
Test run of the fkuid for granulation Top spray was done for both minimum and maximum load of the equipment. Test run of the equipment for wurster coating Bottom spray was done processro both minimum and maximum load of the equipment using non peril seeds.
The equipment qualification for Design, Installation, Operation and Performance was successfully done.