Budhraja Packaging Pvt. Ltd
The company has latest technology for printing i.e. Computer to plate which is effective in processing printing in multiple ups and minimize the errors.
Keeping Quality as a standard we have a technology i.e. Tech for Check, which is effective in checking all defects of printing.
We have technology for online Braille i.e. Accubraile.
Production and control of cartons and Leaflets are carried out in compliance with GMP requirements and others international standards In 2010, reconstruction and modernization of factory was made, improving the capacities with new equipment for production of Carton and Leaflets.
Budhraja packaging has been the trusted supplier of many pharmaceuticals clients.
Budhraja Packaging Pvt.Ltd. covers the area of 6664.66 m² & RCC construction building in 25000sq./feet .The site is located in the G.I.D.C. UMBERGAON (located 6 km. from the town of Umbergaon) and 150 km near from Mumbai.
Production and control of cartons and Leaflets are carried out in compliance with GMP requirements and others international standards In 2010, reconstruction and modernization of factory was made, improving the capacities with new equipment for production of Carton and Leaflets.
Budhraja packaging has been the trusted supplier of many pharmaceuticals clients.
Budhraja Packaging Pvt.Ltd. covers the area of 6664.66 m² & RCC construction building in 25000sq./feet .The site is located in the G.I.D.C. UMBERGAON (located 6 km. from the town of Umbergaon) and 150 km near from Mumbai.
Personnel Hygiene requirements including clothing
Personnel working in the manufacturing plant should wear the clean working clothes, trousers, gloves, caps in accordance with procedure. Working clothes and their quality should be appropriate for the work process and working environment to enable products safety form contamination. Every person is expected to come to work clean, tidy, and healthy. In manufacturing and laboratory spaces, consumption and keeping of food and drinks as well as smoking are prohibited. Direct contact between operator’s hands and starting materials, parts of equipments coming in direct contact with product, is not allowed. All personnel after working must wash their hands hygiene areas. These areas should be provided with appropriate washing agents (liquid soap, paper towels or Hand driers).
Personnel working in the manufacturing plant should wear the clean working clothes, trousers, gloves, caps in accordance with procedure. Working clothes and their quality should be appropriate for the work process and working environment to enable products safety form contamination. Every person is expected to come to work clean, tidy, and healthy. In manufacturing and laboratory spaces, consumption and keeping of food and drinks as well as smoking are prohibited. Direct contact between operator’s hands and starting materials, parts of equipments coming in direct contact with product, is not allowed. All personnel after working must wash their hands hygiene areas. These areas should be provided with appropriate washing agents (liquid soap, paper towels or Hand driers).
Premises and Equipment
Budhraja Packaging Pvt.Ltd. produces Cartons & Leaflets. System of horizontal production line is implemented in ground floor of the factory, on area of 25000m². All standards are obtained. The used material meets the requirements of GMP standards, with which the required quality of the product is obtained.
Capacity of system for Cartons & Leaflets
The technological process is carried out on the following equipment.
•Reel sheets cutter with capacity of 10000 sheets/hrs.
•Printing Machine with capacity of 35000 sheets/shift.( Leaflets )
•Printing Machine with capacity of 35000 sheets/shift ( Cartons )
• Cutting machine with 70000 sheets/ shift
•Punching (Cartons ) with 25000sheets/shift
•Leaflet Folding with 8000nos./hrs.
•Carton Pasting machine with 30000nos./hrs.
•Final packing
Budhraja Packaging Pvt.Ltd. produces Cartons & Leaflets. System of horizontal production line is implemented in ground floor of the factory, on area of 25000m². All standards are obtained. The used material meets the requirements of GMP standards, with which the required quality of the product is obtained.
Capacity of system for Cartons & Leaflets
The technological process is carried out on the following equipment.
•Reel sheets cutter with capacity of 10000 sheets/hrs.
•Printing Machine with capacity of 35000 sheets/shift.( Leaflets )
•Printing Machine with capacity of 35000 sheets/shift ( Cartons )
• Cutting machine with 70000 sheets/ shift
•Punching (Cartons ) with 25000sheets/shift
•Leaflet Folding with 8000nos./hrs.
•Carton Pasting machine with 30000nos./hrs.
•Final packing
All machines are constructed according to GMP regulations and all surfaces being exposed to product are made in stainless steel. The complete manufacturing process is checked by in-process control, carrying out the analyses, measuring of semi-finished products, and finished products. The major equipment for in-process control is composed of:
-pH meter
-Weighing Balance
-Vernier Calliper
-Thickness gauge
-Template (10X10cm) for GSM checking
-pH meter
-Weighing Balance
-Vernier Calliper
-Thickness gauge
-Template (10X10cm) for GSM checking
The responsible personnel for validation are composed of experts in the area of production, quality control, technical personnel. For this purpose are made protocols for validation and calibration of the instruments. In addition, plan-programs for calibration and maintenance of the equipment are made.Budhraja Packaging Pvt. Ltd. has contracts with competent companies for maintenance of the technical system and equipment.
Cleaning procedures for manufacturing areas and equipment are defined in SOP’s. Preparing of cleaning material and cleaning techniques are précised within the SOP’s. Kinds of cleaning agents as well as cleaning frequency are defined in SOP’s.
Documentation
Documentation system in Budhraja Packaging Pvt.Ltd. in compliance with GMP requirements and it represents a significant element of quality management.
Cleaning procedures for manufacturing areas and equipment are defined in SOP’s. Preparing of cleaning material and cleaning techniques are précised within the SOP’s. Kinds of cleaning agents as well as cleaning frequency are defined in SOP’s.
Documentation
Documentation system in Budhraja Packaging Pvt.Ltd. in compliance with GMP requirements and it represents a significant element of quality management.
In Budhraja Packaging Pvt.Ltd. there is an established and documented system of documentation control, covering systematic, process and external documentation.
All activities related to issuing, approving, revising and filling of documentation and data are defined in documented procedure and instructions.
Documents are stored in various places, depending on nature of document.
Revisions on controlled documents are subject to the requirements of preparing, checking, issuing and approving as the original document and they non-valid documentation in immediately withdrawn from use.
Budhraja Packaging Pvt.Ltd. applies the documentation system through which the status of controlling and testing the materials and equipment in every phase is defined, from receipt, control and testing during the process, through final control up to the final verification and delivery. Entering control and validated test methods are applied for checking of raw materials quality and packing materials for compliance with specification. Preceding the verification and delivery are finished products control and checking of finished products quality compliance with specification. All checks on compliance with specifications for raw materials, packing materials, intermediate products and finished products are recorded in appropriate forms and as records on quality, verified and approved by competent persons, are filled in the places and for the period as defined in procedures on quality records
Receipt control, in-process control and final control are made by employees responsible for quality control. Records on these activities are filled by employees for quality control.
Applying of the established documentation system enables that only the material or product which passed all required controls and which is brought in compliance with all specified quality requirements gets approved for any further process.
All activities related to issuing, approving, revising and filling of documentation and data are defined in documented procedure and instructions.
Documents are stored in various places, depending on nature of document.
Revisions on controlled documents are subject to the requirements of preparing, checking, issuing and approving as the original document and they non-valid documentation in immediately withdrawn from use.
Budhraja Packaging Pvt.Ltd. applies the documentation system through which the status of controlling and testing the materials and equipment in every phase is defined, from receipt, control and testing during the process, through final control up to the final verification and delivery. Entering control and validated test methods are applied for checking of raw materials quality and packing materials for compliance with specification. Preceding the verification and delivery are finished products control and checking of finished products quality compliance with specification. All checks on compliance with specifications for raw materials, packing materials, intermediate products and finished products are recorded in appropriate forms and as records on quality, verified and approved by competent persons, are filled in the places and for the period as defined in procedures on quality records
Receipt control, in-process control and final control are made by employees responsible for quality control. Records on these activities are filled by employees for quality control.
Applying of the established documentation system enables that only the material or product which passed all required controls and which is brought in compliance with all specified quality requirements gets approved for any further process.
Production
Production in performed in compliance with technological procedure. During production, the batch production and batch packaging records are filled in individual phases, including key parameters, are controlled and documented by in-process control. Separate appropriate procedures are followed for handling of the raw materials, packaging materials, bulk materials and finished products, from taking samples, releasing from quarantine and their final storage.
The process goes under following: ( Leaflets )
-Sheet cutting on sheets cutter machine
-Printing
-Sheets checking
-Sheets cutting as per actual up size
-Again up checking
-Leaflets folding
-Packing
-Final checking
The process goes under following : ( Cartons )
-Sheets cutting on sheets cutter machine
-Printing
-Punching ( with Braille / Embossing )
-Pasting ( with inline Braille )
-Packing
-Final checking
Production in performed in compliance with technological procedure. During production, the batch production and batch packaging records are filled in individual phases, including key parameters, are controlled and documented by in-process control. Separate appropriate procedures are followed for handling of the raw materials, packaging materials, bulk materials and finished products, from taking samples, releasing from quarantine and their final storage.
The process goes under following: ( Leaflets )
-Sheet cutting on sheets cutter machine
-Printing
-Sheets checking
-Sheets cutting as per actual up size
-Again up checking
-Leaflets folding
-Packing
-Final checking
The process goes under following : ( Cartons )
-Sheets cutting on sheets cutter machine
-Printing
-Punching ( with Braille / Embossing )
-Pasting ( with inline Braille )
-Packing
-Final checking
Infrastructure
Production Area Leaflets
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11000 Sq./ feet
|
Production area Cartons
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10000 Sq./feet
|
Office area
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4000 Sq./feet
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Sr.No.
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Documents
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Used By
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1
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Quality Policy
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All
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2
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Quality Manuel
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All
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3
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Quality Plan And Guidelines
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All
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4
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SOP - Quality system
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All
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5
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Technological, Registration, Manufacturing control documentation, Operational and
examinational instruction, etc
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All
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6
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Records
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All
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info@budhrajapackaging.com
