Our Services and Solutions
Unsurpassed Quality Services
At SYRVIATEK, our assessment service is the key to success in the industry
SYRVIATEK has an experienced workforce that is intimately familiar with a vast array of pharmaceutical inspection processes. Knowing what you currently have and where you would like to go is the first priority in any goal. At SYRVIATEK, we meet with you and get an understanding of your business goals and objectives. We then gather all the relevant data as to how your current processes are designed and configured.
Knowing your current assets and where you would like to take your organization is an important step in advancement. Planning is key to success and SYRVIATEK is here to assist you with the all-important planning stage before we work together to implement your plan. SYRVIATEK Corp services include but are not limited to:
- Automatic Inspection Challenge Standards
- Parenteral Manual Inspection Defect Panels for Training – Defect Standards
- Parenteral Fill Volume Standards
- Test Units for protocol execution
- Units evaluation using magnification and forensic analysis – evaluation
- Glass Breakage Patterns recognition – Evaluation
- Particle presence confirmation and ID – Evaluation
- Inspectors Training, Certification, Defect Familiarization and Recognition.
- Knapp Studies
- Validation Project Management
- Construction/Qualification Project Management
- Product Transfer Project Management
- Facility and Utility Commissioning and Validation
- Validation Master Planning
- Process Equipment Validation Process Validation
- Computer Systems Validation
- Cleaning Validation
- Re-Qualification
- Standard Operating Procedures Preparation
- Vendor qualification and inspection of suppliers Contract Manufacturing
- Laboratories Methods Validation
- Quality Assurance Systems Gap analysis, Investigations, CAPA’s and Technical writing
- Development Training and education in GMP’s, GLP’s and 21CFR Part 11
- Technical Support to the day to day filling and packaging operation resolving technical issues during the operation. The support provided includes:
- Technical Protocols for process improvement.
- Root Cause Analysis generation for complaints related to complex scenarios.
- Project Management for Sterilization Project.
- Quality oversight during qualification and facility start up activities includes.
- Cleaning, Sterilization and Preparation of components – review and approval of equipment charts/printout from CIP Skids, Ultrasonic, Parts Washers, and Autoclaves as evidence per status. The task also includes approval of corrective and preventive maintenance using the MAXIMO software.
- Functional / Characterization Plans & Reports– review and approval of test scripts (test runs and technical reports) intended to establish the equipment functionality and/or to define critical process parameters. Evaluate the data and reports from these studies and follow through qualification studies and SOP’s.
- Standard Operating Procedures – develop and/or edit quality operation procedures for the oversight of the dispensing, buffer prep, formulation, and component prep areas.
- Review and approval of operational SOP’s. Develop a training module for quality specialists supporting future commercial operations.
- Buffer preparation
- Microplate coating process
- Incubation cycles
- Detection antibodies standard preparation
- Kit packaging and shipping
Syrviatek Laboratories will have as part of its new manufacturing technology the introduction of the manufacture of ELISA (Coating and Blocking) tests for the use of diagnostic tests. Syrviatek specializes in the manufacture of these immunoassays in its laboratory facilities in Carolina, Puerto Rico. Syrviatek currently has a laboratory specialized in the manufacture of visual inspection standards to support the validation processes of defect rejection processes in the injectable pharmaceutical industry. Now with this new technology Syrviatek seeks to expand its operations to the area of immunoassays to support the medical industry and its diagnostic tests.
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