Pharmaceutical Industry

It depends on the specific application. For APIs and highly sensitive products, new containers are recommended or required. For less critical applications like cleaning solutions, excipients, or process water, Grade A reconditioned containers with documented food-grade history may be acceptable. Always verify requirements with your quality department and regulatory guidelines before using reconditioned containers.

We provide comprehensive documentation including Certificate of Cleaning, material certifications, batch/lot tracking, dimensional specifications, and chain of custody records. For new containers, we also provide Certificate of Analysis and FDA food-contact compliance documentation. All documentation can be customized to meet your specific quality system requirements.

Our cleaning process follows pharmaceutical industry standards with defined parameters for time, temperature, cleaning agent concentration, and rinse water quality. We maintain cleaning validation documentation that includes visual inspection criteria, rinse water conductivity limits, and microbial testing where applicable. We can work with your quality team to ensure our process meets your validation requirements.

Lead time varies depending on the type and quantity needed. New containers typically ship within 1-2 weeks. Reconditioned containers require our full cleaning and documentation process, usually 2-3 weeks depending on volume. For time-sensitive needs, we maintain stock of pre-cleaned containers that can ship more quickly. Contact us to discuss your timeline requirements.

We can supply containers suitable for controlled substance manufacturing, but the containers themselves do not carry DEA registration. Your facility must maintain appropriate DEA licensing and security measures. We can provide containers meeting your physical security requirements (tamper-evident closures, serialized containers) with appropriate documentation for your compliance records.

New HDPE containers we supply are manufactured from pharmaceutical-grade resins that comply with USP <661> requirements for plastic packaging systems. For reconditioned containers, USP compliance depends on the original container specifications. We can provide material certifications and help you assess whether specific containers meet your USP requirements.

Our standard cleaning process significantly reduces bioburden but is not validated for endotoxin removal. For applications requiring low endotoxin levels, we recommend new containers with documented endotoxin testing, or we can work with your quality team to implement additional cleaning steps with appropriate testing. Always validate container preparation for your specific product requirements.

For sterile manufacturing applications, we recommend new containers that are then subjected to your facility's sterilization process. We can provide containers cleaned to a high standard that are ready for terminal sterilization. For aseptic processing, containers would need to be sterilized and handled within your controlled environment according to your validated procedures.