Protecting Raw Materials From Virus Contamination

By Marlin Frechette, Irvine Scientific

Protecting your raw materials is a vital part of your process – and one that should be taken seriously.  Repercussions like plant shut-downs and drug shortages — stemming from events like virus contamination — can be far-reaching and difficult to overcome. To help safeguard your product, and to avoid potential adverse events, we recommend you consider the following precautionary steps.

Raw Materials Handling

A proper raw material program provides a gateway of assurance to consistency in finished goods. The critical principles built into our program incorporate the belief that the management of the raw material program and supply chain are the foundation for all things quality.

The following principles are important to ensure quality:

• Dual Sourcing of Raw Material - Dual sourcing translates to lower risk, mitigates out of stock situations, and improves inventory management. Whenever possible, at least two qualified vendors are approved for each raw material.
• Sourcing of the Highest Grade Materials - High compendia-grade components assure the highest purity and consistency of product.
• Customer-specific raw material requirements - We recognize customer-specific requests exist and as a result we have a system in place to support custom raw material sourcing and/or specifications. We take a flexible and collaborative approach in custom raw material control to meet customer needs.
• Continuous vendor improvement - We practice on-going, continuous, and pro-active quality monitoring of vendors. This provides us with control and advance preparation when it comes to informing our customers with change notifications.

Quality Control Testing

QC tests:

• Powder testing includes: pH, Moisture, osmolality, bioburden, and endotoxin
• Liquid testing includes: sterility, pH, osmolality, and endotoxin

Stability Study/Analysis:

• These tests are also available to assist you in establishing an expected shelf-life for custom formulations. Cell culture media stability for custom formulations is also available to meet specific customer requirements. These services are performed by our quality control department, under cGMP conditions using validated methods and assays.

Generation And Development Of A Custom Stability Testing Protocol:

• These services are designed to meet your specific requirements, including testing methods, product specifications, length and scope of study.

Product samples are stored in controlled storage areas, in chambers that have been thermal mapped and are temperature monitored 24 hours / day to ensure proper and consistent results. Optional additional testing available can include, but is not limited to, the following:

o Amino Acid Analysis (HPLC)

o Vitamin Analysis (HPLC)

o Endotoxin (LAL Gel Clot or Kinetic Chromogenic)

o Glucose

o Cell Growth/ Function

o Lipids/Fatty Acids

o Cholesterol

o Osmolality

o pH

o Solubility

o Moisture (Karl Fisher Titration)

o Microbial Limits (Bioburden)

o Sterility

o Heavy Metals/Elements screening (ICP-MS)

o Mycoplasma Screening

Custom Media Services

Irvine’s media program is specified to your unique requirements, with communication being an essential factor every step of the way. Strong collaboration between suppliers and customers is a necessity, and we ensure that your questions and concerns are addressed — both during the order and after your product is received. Our organization is structured to provide customer accessibility to our key team members, and effective communication among all our internal departments. At Irvine Scientific, we strive for mutually beneficial long-term relationships while assisting you in completing your projects on-time.

A high performing media is essential to the success of your program. We realize that controlling this from prototyping, through scale-up or scale down modeling, at troubleshooting, and finally, at production requires the highest quality and rapid response.

Your media is only as pure as the least pure ingredient. A stringent raw material program assures a final product that exceeds all quality requirements. Irvine Scientific achieves lot-to-lot consistency through highly detailed manufacturing procedures, precise tolerances on all measures, and strict in-process acceptance ranges.

Facility and Capacity Considerations

Our facilities and infrastructure are designed to provide the highest level of support to our customers. State of the art manufacturing facilities provide for redundancy of manufacturing and quality systems, while enhancing our capacity. From highly regulated medical environments, to basic research, to commercial stages of therapeutics and vaccines, our products and services meet the highest quality and regulatory standards. Uninterrupted and rapid product supply is critical, so Irvine Scientific is continually improving to meet the challenges our customers face.

QUALITY

Our extensive history supporting regulated products assures our practices thoroughly conform to the International Standard Organization (ISO) and United States Food and Drug Administration (FDA).

This knowledge is the foundation for our facility planning, comprehensive approach to validation, qualification and certification of methods, equipment, and processes.