Stability Testing and Storage

Stability Testing and Storage

Test Articles

We offer services in support of these test articles.

 
 

Stability Testing and Storage

Lancaster Laboratories provides secure storage and experienced testing of your samples according to your specified procedures and timetables. We also offer testing for samples stored at your facility in addition to any project management and consulting you might need.

Our capabilities include biochemistry, chemistry, molecular and cell biology and microbiology testing services to support your bio/pharmaceutical product. We can use your procedures or those found in any compendium to support your stability needs. Our Stability staff can also design studies specific to your project needs, and our experienced Method Development and Validation team is available for any additional services you may require.

Why Choose Lancaster Laboratories?

  • We offer the largest Stability Testing and Storage Facilities with more than 25 different chamber set points and over 23,000 cubic feet of storage space, housed in a secured area, continuously monitored by our validated Kaye monitoring system and supported by a fully validated computerized stability laboratory information management system (LIMS) to manage and ensure proper execution of your studies.
  • Our facilities can meet the specific requirements of any project with the ability to provide alternate temperature and humidity conditions.
  • Our online data access portal, LabAccess.comSM, features a stability calendar that displays the progress of your stability studies with detailed links to information posted, allowing you to link to a sample number and see live data. You can also link to your overall protocol plan in our document control system, ensuring complete alignment between your requirements and scientific procedures.

Leadership of Group:

 

Mark Kaiser – DirectorNearly 30 years with Lancaster Laboratories

Jeannine Schreiber – ManagerNearly 30 years with Lancaster Laboratories

 

 
 

Support Services Offered

  • Marketed & Clinical Stability & Release Testing
  • Support of Method Validation
  • Comparator Product Testing
  • Protocol Writing
  • Storage & Distribution of Reference Materials
  • Retain Program Management

Storage Systems and Capacity

  • More than 23,000 cubic feet of storage space
  • More than 25 different set points for the stability chambers

Storage and Distribution of Reference Materials

We provide full-service support for the storage, testing and distribution of your critical biologic reagents and reference standards, including:

  • Aseptic aliquoting of bulk biological reagents and reference materials
  • Storage, including -70C, vapor phase liquid nitrogen and -20C
  • Cold-chain management and secure-monitored shipping for your materials
  • A full complement of biopharmaceutical services to support the stability testing of your materials

Retain Program Management

Upon arrival at Lancaster Laboratories, cGMP reserve samples are documented as to date and time of receipt and taken directly to our reserve sample storage area. We take inventory, compare the inventory with protocols and then log these samples into our reserve sample-tracking database. A cGMP quality check is performed as required for samples received from third-party manufacturers. This check can include but is not limited to: label quality, lot number, print quality, container quality and container closure. The inspection can be tailored to meet your in-house standard.

Per your requirements, reserve samples can be scheduled for physical observation analysis. We generate “pull reports” from our scheduling database for each workday, pull the samples as scheduled and log the samples due for testing into our LIMS. You will then receive an acknowledgment letting you know that the appropriate samples have been pulled and are scheduled for the required testing. All steps of the storage and testing process are tightly controlled and accurately documented.

Current Stability Chambers and Set Points

  • Cryogenic/LN2
  • -80C (+/-10C)
  • -70C (+/-10C)
  • -30C (+/-5C)
  • -20C +/-5C cycling to 40C +/-2C Ambient %RH
  • 5C (+/-3C)
  • 7C +/-2C / Ambient %RH
  • 20C (+/-5C)
  • 22C/Ambient %RH
  • 25C (+/-2C)
  • 25C/40%RH (+/-2C / +/-5%RH)
  • 25C/60%RH (+/-2C / +/-5%RH)
  • 25C/60%RH Light (+/-2C / 5%RH)
  • 30C/35%RH (+/-2C / +/-5%RH)
  • 30C/60%RH (+/-2C / +/-5%RH)
  • 30C/65%RH (+/-2C / +/-5%RH)
  • 30C/75%RH (+/-2C / +/-5%RH)
  • 32.5C (+/-2C)
  • 35C/35%RH (+/-2C / +/-5%RH)
  • 40C (+/-2C)
  • 40C (+/-2C)
  • 40C/20%RH (+/-2C / +/-5%RH)
  • 40C/75%RH (+/-2C / +/-5%RH)
  • 50C (+/-2C)
  • 60C/Ambient %RH
  • 60C/15%RH (+/-2C / +/-5%RH)
  • 70C (+/-2C)
  • 70C/15%RH (+/-2C / +/-5%RH)

Contact

Request additional information to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.