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Resources > Case Studies

Syrviatek Proudly Serves Leading Pharmaceutical & Biotech Brands Around the World

An International Full-Injectables Visual Inspection Test Set Provider, ELISA Manufacturer & Consultancy

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Wockhardt Pharmaceuticals

Location
Aurangabad, India

Service Overview
Assessment, approval, and implementation of visual inspection kits.

Service Details
- Visual inspection defect categorization and classification for syringes, vials, and cartridges.

- Visual inspection kits creation for syringes and vials (clear liquid and suspensions).

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Amgen Manufacturing Limited

Location
Juncos, Puerto Rico

Service Overview
Technical support of the day-to-day filling and packaging operation to resolve technical issues.

Service Details
- Inspection.
- Vials and syringes cosmetic defect evaluation and inspectors certification.
- Creation of challenge kit for inspection machine challenge.
- Technical protocols for process improvement for visual and automatic inspection.
- Evaluation of defects including forensic analysis to determine product impact and implementation of CAPAs.
- Creation of visual inspection kits, defective units for automatic inspection protocols, validation protocols, and inspector certifications.

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ABBVie Biotechnology Operations

Location
Barceloneta, Puerto Rico

Service Overview
Visual inspection assessment and consultation.

Service Details
- Creation of automatic inspection standards and assessment.
- Consultation services provided for automatic inspection approach and last update on PDA.

Biocon

Location
Johor, Malaysia

Service Overview
Visual inspection kit creation and consulting for visual inspection process.

Service Details
- Creation of vial and cartridge visual inspection kits.
- Creation of defective units for automatic inspection validation protocols.
- Creation of training defect panels for inspector certification.
- Consulting and advice regarding the visual inspection process.


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Baxter

Location
Northcove, USA | Ahmedabad, India | Alliston, Canada

Service Overview
Visual inspection kit creation and consulting for visual inspection process.

Service Details
- Creation of vial, IV bag, ampule, and bottle visual inspection kits.
- Creation of defective units for automatic inspection validation protocols and inspector certification.
- Consulting and advice regarding the visual inspection process.


Kashiv

Location
New Jersey & Illinois, USA

Service Overview
Visual inspection kit creation and consulting for visual inspection process.

Service Details
- Creation of vial and syringe visual inspection kits.
- Creation of defective units for automatic inspection validation protocols and inspector certification.
- Consulting and advice regarding the visual inspection process.

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Omics Global Solutions

Location
Rio Piedras, Puerto Rico

Service Overview
ELISA plate coating and testing.

Service Details
- ELISA plate coating and blocking.
- ELISA plate quality control testing.
- Detection antibodies and standard preparation.

Intas Pharmaceuticals

Location
Ahmedabad, India

Service Overview
- Assessment, approval, and implementation of the entire visual inspection program.
- Assessment and improvement of the manual packaging lines.

Service Details
- Visual inspection defect categorization, and classification for syringes, vials, and cartridges.
- Visual inspection kits creation for syringes and vials.
- Generation, approval, and implementation of procedures and visual inspection techniques.
- Inspection kits generation and certification.
- Training and certification of visual inspectors.
- Visual inspection batch record.
- Support for packaging and inspection deviations.
- Remediation of packaging and inspection areas for improvement on FDA regulation.
- Evaluation, improvement, approval, and implementation of batch record.
- Planning and organization.
- Segregation of areas increasing output at 50%.
- Improvement and evaluation of quality on the floor.
- Training and certification.

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