Fill and Finish Operations - - BioPharm International

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Fill and Finish Operations


BioPharm International



Particulate Control
The Healthcare Compliance Packaging Council (HCPC) recommends that labels be easy to read, include the expiration date, and illustrate the product. Labels should have consistent placement of warnings and concentrations and should be free of technical jargon and abbreviations. HCPC recommends that packages be bar coded and include detailed instruction sheets. Consumers want packages that provide easy access; that are environmentally friendly by generating minimal trash; that fit in the hand, purse, or pocket; and that protect products after opening. HCPC suggests that packages adhere to standards without looking like other products. They should be easy to open and reclose, come in unit-dose form, and discourage counterfeiting. The council also says that an ideal package would indicate when one dose was taken and the next due while cost-effectively protecting product stability.

Validation Many departments must sign off on written documents for materials release. Purchasing must audit the vendors. Inspection and receiving departments need to create incoming inspection documents. Safety and environmental departments need to handle special labels for hazardous materials. Chemistry and microbiology need to decide on the tests for lot-to-lot evaluations. Toxicology must validate the lot-to-lot toxicity tests. The specifications department must write product SOPs and specifications. Project engineers need to explain what materials can be used in the process. Emergency response and evacuation planning may be required when hazardous products are used.

The regulatory involvement in packaging and shipping may involve the Occupational Health and Safety Administration (OSHA), the Environmental Protection Agency (EPA), FDA, the Nuclear Regulatory Commission (NRC) (for radioactive materials or wastes), state agencies for employee health and safety, air and water standards, and local agencies fire districts, air and water standards authorities).

The Department of Transportation (DOT) and Federal Aviation Administration (FAA) oversee the movements of hazardous materials by rail, waterway, road, and air. All shipments of both products and wastes must be properly labeled, supplied with proper manifests from site of origin to final destination, and packaged in approved containers. Regardless of what contractors are hired, the product sponsor is responsible and liable for any hazardous material. Sponsors must fill out Uniform Waste Manifests. Recombinant DNA is primarily regulated by NIH, which determines its hazard classification and handling procedures.

Validating labels. Validating the labels means choosing the right labels and equipment, operator training, process flow and controls, and SOPs for quarantine, inspection, release, handling, shipping, and product inserts. The machine vision system and the packaging line weight checker should be validated by using limited samples with known defects: labels with wrong lot numbers or expiration dates, packaged products missing product inserts, and product containers with low-fill volumes.


Issues with Prefilled Syringes
Validating storage. Increasingly, FDA asks that shipped and stored material be validated. Disposable or reusable temperature or temperature-humidity data loggers can be packaged with the product to monitor conditions along the supply chain and pinpoint deviations. Temperature-sensitive packaging must meet ASTM D-3101 (The Standard Test Method for Thermal Insulation Quality of Packaging). FDA's guidance for packaging is The Container Closure System for Packaging Human Drugs and Biologics (May 1999). Title 21 of the Code of Federation Regulations contains additional regulations on packaging and shipping: Part 201 outlines label procedures, Part 600.15 details shipping temperatures for various therapeutics, Part 601.12 addresses changes to a label, and Part 601.45 discusses promotional material. Real-time shipping validation studies include temperature deviations and shaking tests.


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