Unicep applies rigorous standards to achieve high quality assurance. Following is a summary of Unicep’s Quality System.

Material Storage & Handling  

1. Customer supplied product is received in bulk containers. 
2. Container and material are inspected visually for damage, contamination, and quantity or other inspection criteria provided by the customer.
3. Upon QA acceptance, material is placed in temperature-controlled locked storage until the packaging run.
4. Any special storage or handling procedures are confirmed in writing on a customer-approved Specification Sheet.

Production

All phases of manufacturing, including procedures and methods, are  in compliance with Unicep Packaging's ISO9001: 2000 registered Quality System.

1. Quality Assurance and qualified operators review the customer-approved Specification Sheet and the customer-approved Work Order are reviewed by prior to any production run to verify all aspects of the order.
2. Material is retrieved from locked storage and inspected visually for quantity, contamination, and appearance as described on the Specification Sheet.
3. Various methods are available for transfer of material from bulk container to MicroDose® machine. The method of choice for each production run depends on customer specifications and the characteristic of the product.
4. Various fill systems are available for filling material into the MicroDose® units. The method of choice for each production run depends on customer specifications and the characteristic of the product.
5. The exact method for manufacture of the MicroDose® vials is proprietary but may be described as a modified Blow-Fill-Seal system. Blow-molded plastic parts are formed, filled and sealed in an integrated in-line manufacturing process. Various interchangeable molds are used to control vial size and shape. Standard MicroDose® vial  material is low-density polyethylene. A medium density polyethylene plastic is also available.
6. A combination of in-line and post QC inspections methods are used to ensure seal integrity, fill level, and proper appearance.
7. Upon final inspection by Quality Assurance, finished units are released for shipping or for additional packaging as per customer specifications.

Inspections

Our Sandpoint, Idaho facility receives regular FDA and ISO9001 inspections.

Licenses and Certifications

• ISO9001:2000 Certification achieved in July of 2003
• ISO9001:1994 Certification achieved in August of 2001
• ISO9001 Certification achieved in August of 2000
• FDA Registered Facility for packaging of drugs
• FDA Registered to package Class II medical devices

Compliances

• FDA QSR’s
• EN46001 Standard

Facility Tours/Audits

Unicep welcomes facility visits and audits by customers. Please contact your customer service representative to schedule your visit.