HyClone qualifies utilities and equipment and validates production processes. HyClone’s philosophy is summarized in its Validation Management Standard Operating Procedure. HyClone’s validation team plans and supervises the qualification of key production equipment and the validation of production processes in compliance with the principles of cGMP and ISO 9001:2000.

HyClone’s validation team identifies new product and process validation requirements and works with DCAT, product development, and production personnel to create validation protocols and document all validation activities.

When each validation run has been completed in sufficient replicates to insure reproducibility, a validation summary is prepared. Summaries are reviewed and submitted for approval. Validated processes are revalidated when a significant change is made to a process.

Media and other sterile-filtered liquid fills are validated twice-yearly using aseptic filling. At least one validation run of each validated sterilization load configuration is performed annually. Other validated processes are reviewed yearly.

Certain of the quality information described on this page can be shared with customers subject to appropriate confidentiality assurances.

Equipment Validation
HyClone’s validations are performed to assure that all products meet HyClone quality standards and comply with cGMP guidelines. Validation provides opportunities to understand and improve production processes and assures that quality is built into the product. Validation of production processes is based on the qualification of subordinate equipment. Equipment qualifications include the following:

• Equipment Identification
• Intended Use
• Equipment Specifications
• Support Utilities
• List of Procedures Pertaining to Proper Intended Use
• Manufacturer’s Manuals
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Training of User and Maintenance Personnel
• Summary
• Approval by Production, Validation, Quality Assurance, and Product Development/ Engineering as applicable

Validation Master Plans
Master plans are written for product types or production processes. Validation Project protocols are written as defined in the applicable Validation Master Plan. Product validation demonstrates compliance with release criteria and approved marketing claims.

Processes are challenged and monitored during validation. Changes in production processes are reviewed by Validation, Product Management, and Quality Assurance to determine if revalidation of the process is required before implementation of the change.

Validation Project protocols contain the following:

• Objective
• Responsibility
• Acceptance Criteria
• Supplies
• Equipment
• Procedures
• Procedure Approval
• Results
• Summary
• Review and Approval
• Attachments
• References