Keep sterile label claims intact as your process evolves
When materials, packaging, or production conditions change, you need a structured path to demonstrate continued process control. We develop the risk evaluation and equivalence rationale that keeps regulators and auditors confident.
Documented risk evaluation at every change
Equivalence rationale development
Paper review when full revalidation is not required
Support during scale-up and production transfers
Common scenarios that bring teams to Andersen Scientific
We help maintain sterile label claims without unnecessary revalidation by emphasizing documented risk evaluation and equivalence rationale.
Periodic Requalification
Scheduled requalification programs to confirm ongoing process control and performance stability.
Process Adoption
Adoption of previously validated cycles with structured documentation to support continued sterile label claims.
Equivalence Rationale Development
Technical justification demonstrating equivalence when materials, loads, or configurations change.
Manufacturing Scale Alignment
Support during scale-up, production transfer, or load configuration adjustments.
Registered and audited for medical device work
ISO 13485 Certified & FDA Registered
Est. No. 1064858
FDA Innovation Challenge 2 Winner
Recognized for responsible innovation
Environmental Stewardship Award
Small Business recipient
NC Permit Exemption
Exceptionally low emissions