Bottling manufacturing

Packaging and Labeling Support Services

 

Product packaging for the life sciences must embody quality and value above all else. It is a representation of the quality and safety of the product it contains and your organization as a whole.

Lean Biologix has expertise in commercial and clinical packaging operations whether internal or at CMO locations. 

Package development

Packaging and labeling for products distributed  in a regulated market need to meet customer expectations in terms of quality and utility but also comply with all regulatory requirements for each market.  These factors along with manufacturing considerations are the keys to developing successful packaging for pharmaceutical products.  

  • Primary container specification
  • Secondary packaging design and procurement
  • Printing and materials specification
  • Supplier selection, auditing and validation

Equipment specification and testing

Equipment specification and installation support

  • Pre-FAT and FAT will be initially performed at the manufacturer’s site to ensure the equipment operates as it is intended to meet all user requirements.  The same would be performed again once the equipment has been delivered to the client’s site in the form of SAT where IQ, OQ and PQ will be performed.  

Primary liquid filling equipment

  • Procuring and installing a liquid filler starts with understanding the key  performance requirements.  Clear acceptance requirements and understanding how the equipment will meet each one is crucial to success.

Primary and secondary label application operations and equipment

  • Labeling operations and equipment options vary considerably with manufacturing demand requirements.  An efficient process is designed to produce quality products at speeds and volume required to meet the market demands utilizing the available resources.

Barcoding and ERP (SAP & OPM) integrations

  • Most people know a barcode when they see one but what they don’t know is the decisions behind the selection of the code symbology and printing methods.  A barcode is more than simply a replacement of human keystrokes and must work hand-in-hand with the system that uses them.

Process design and documentation support

  • A packaging process must be designed to efficiently meet demand without over producing and creating waste.  Standard operating procedures are required to train operators on best practices. For long-term performance and compliance, scheduled Preventive Maintenance and calibration plans must be created with the agreement of the client’s maintenance/metrology team and/or with the manufacturer.

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