Release Testing

Release Testing

Release Testing

To support your commercial product Release Testing needs, Lancaster Laboratories offers you experienced testing for any type of formulation. Our multi-shift staff has performed Release Testing of in-process materials as well as finished products. We can also manage your product retain program.

Why Choose Lancaster Laboratories?

  • We have in-depth experience working with every type of formulation and have the flexibility and extensive instrument capacity within our team to meet the ever-changing demands of production schedules and timelines.
  • We can meet all EU Batch Release requirements. This testing is performed at our Ireland facility by experts who are intimately familiar with EU requirements. Our harmonized approach to providing service ensures you of the same level of expertise and quality at all of our facilities.

Leadership of Group:

 

Travis Emig
DirectorNearly 20 years with Lancaster Laboratories

Cristi Morgan
ManagerOver 10 years with Lancaster Laboratories

Chrissy Leslie
ManagerOver 10 years with Lancaster Laboratories

 

 
 

Our Experience Includes

  • Capsules (IR/SR)
  • Contact Lenses
  • Implantables (including stents, coronary sleeves, and pacemakers)
  • Injectables
  • Inhalers
  • Ocular Implants
  • Liquids
  • Patches
  • Suppositories
  • Suspensions
  • Synthetic Blood
  • Tablets (IR/SR)

Testing Available

  • Stability & Release Testing
  • Dissolution Testing
  • Physical Testing
  • Cleaning Validation
    • We offer IMS methodology. The accuracy, precision, linearity and detection limits produced by IMS methods make it an ideal choice for cleaning validation work.
  • Moisture Analysis
  • Container Closure Testing
  • EU Batch Release
  • Microbiology

Instrumentation Used

  • LC/MS/MS
  • HPLC
  • GC
  • IC
  • GPC
  • GC/MS
  • KF
  • SEC
  • TOC
  • Dissolution Baths (Apparatus 1,2,4,5, and 7) (Distek/Varian/Sotax)
 


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 laboratory information management system (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.

Contact

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