SYLO USA · Customer policies
Manufacturing and Lyophilization Project Policy
Approvals and commitments under these policies must be confirmed in writing by SYLO USA LLC through an authorized representative. This requirement does not limit customer rights or delay remedies required by law.
Technical brief and feasibility
Provide the research purpose, material or formulation, starting quantity or volume, desired presentation, containers and closures, processing requirements, target timing, and documentation needs. SYLO reviews technical questions and feasibility before defining the quotation. The site identifies manufacturing to specification, lyophilization, and project coordination; it does not establish that every requested synthesis, filling, formulation, or validation service is available.
Written project scope
Before a project starts, agree the process scope, responsible performing parties, facilities or approved outside providers where relevant, inputs, development or production stages, deliverables, target quantities, yield or permitted losses, acceptance criteria, test methods, and release documents. Agree whether feasibility or development work is exploratory or carries a defined output commitment. Do not apply production guarantees to exploratory work unless expressly accepted.
Customer materials and instructions
If the project uses customer-supplied materials, formulas, samples, components, or equipment, agree their identity, condition, quantity, supporting records, hazard information, storage needs, compatibility, and receipt arrangements before shipment. The customer must have authority to supply and authorize their use. SYLO documents discrepancies and does not start uncertain or unauthorized processing. Unsolicited deliveries may be refused; they are not an automatic work order.
Processing and project changes
Follow the accepted scope and written instructions. Any material change in formulation, process, quantity, container configuration, testing, or target timing requires a written change order stating cost, schedule, and acceptance effects. If a technical issue prevents the agreed work, notify the customer and agree the next step rather than silently changing the process. No yield, recovery percentage, residual-moisture value, cycle validation, or compatibility result is assumed unless specified.
Completion and release
The scope must identify who reviews results, which deliverables establish completion, and the acceptance review period. Agree the handling of deviations, unresolved results, partial completion, and any rework before release. Approval of processing is separate from a determination of suitability for a prohibited use. Batch records, COAs, or completion reports are supplied only to the extent defined in the accepted scope.