Combination Drug-Device

Results You Can Trust

Pace Analytical Life Sciences has unmatched expertise in metered dose inhalation and transdermal testing. Partnering with Pace Analytical Life Sciences for your combination drug-device testing needs, you gain an experienced partner that will support and advance your accomplishments.

From Innovation to Market Faster with Pace Analytical Life Sciences

Testing services performed by Pace Analytical Life Sciences depend on the device type. Combination Drug-Device Testing services available through Pace Analytical Life Sciences include:

Pace Analytical Life Sciences leads the industry in quality testing for regulated industries, but retains the flexibility to customize services to meet each customer’s needs.

Contact Pace Analytical Life Sciences about your quality testing needs today.

Microbiology

Pace Analytical Life Sciences’ state-of-the-art Microbiology laboratories offer a full array of cGMP microbiology testing services in support of sterile and non-sterile products, including:

  • Environmental Monitoring
  • Raw Material Testing
  • Method Development and Validation
  • Microbial Contamination Investigation
  • Microbial Limits, USP [61]
  • Antimicrobial/Preservative Effectiveness Testing, USP [51]
  • Facility Bioburden Testing, USP, EP, JP, AOAC, BP
  • Bacterial Endotoxins, USP [85] (Gel Clot)

Our experienced professionals of degreed microbiologists provide expertise in compendial method testing, method development, method validation and custom research projects.

Pace Analytical Life Sciences distinguishes itself by offering access to new, cutting-edge technologies. Our expertise in rapid microbiology techniques, especially bacterial identification and characterization via ribotyping, is unique in the industry. Pace Analytical Life Sciences will partner with you to select the most appropriate technology, perform feasibility studies for your product and help navigate you through validation and FDA approval.

Contact Pace Analytical Life Sciences to discuss your current microbiology testing needs. You can also request a quote online.

Ribotyping: Microbial Identification

As part of the premier Rapid Microbiology service, Pace Analytical Life Sciences now offers rapid, genetic-based identification of microbial isolates using the Dupont Qualicon RiboPrinter®. Pace Analytical Life Sciences invested in the RiboPrinter rapid-bacterial identification and characterization testing technology when the FDA suggested compliance guidelines for aseptic processing and high-speed bacterial identification and characterization testing. This service allows for accurate sub-species identification and characterization of bacteria in 8 hours, in comparison to conventional methods, which can take from 5-14 days.

Physical Testing

The Pace Analytical Life Sciences Physical Testing laboratory analyzes the physical and structural properties of products and materials. Specialties include testing of pressure-sensitive adhesives as well as oxygen and moisture permeability studies, method development and compendial method testing. Our staff of experienced professionals is well versed in developing solutions for a variety of products.

Physical testing studies can be performed in a temperature- and humidity-controlled laboratory.

Contact Pace Analytical Life Sciences to discuss your current physical testing needs. You can also request a quote online.

Analytic Chemistry

The Pace Analytical Life Sciences Chemistry Laboratory offers a complete line of cGMP analytical testing services. Pace Analytical Life Sciences’ analytical services include:

  • Method Development and Validation
  • Assay
  • Impurity Determination
  • Stability Studies
  • Extractables and Leachables
  • Physical/Chemical Characterization
  • USP/BP/JP Testing
  • Raw Material Testing

The laboratory also has considerable experience analyzing low level analytes.

Each of the chemistry professionals has a minimum of five years experience in pharmaceutical and chemical analysis. The laboratory is fully equipped with state-of-the-art analytical instruments (see the Facilities and Certifications page for a full listing). All of the laboratory work is carried out under cGMP, and full QA review is available upon request.

Contact Pace Analytical Life Sciences to discuss your current analytical testing needs. You can also request a quote online.

Metered-dose Inhalation (MDI)

The Pace Analytical Life Sciences chemistry laboratory professionals offer analytical testing solutions with unmatched expertise in metered-dose inhalers (MDI). For the past 10 years, Pace Analytical Life Sciences has been at the forefront of MDI method development and analysis in conjunction with a leading innovator (Fortune 100 Company) of drug delivery systems. Pace Analytical Life Sciences has developed and validated methodologies, performed stability studies and analyzed thousands of MDI samples, both for release and stability testing. Pace Analytical Life Sciences has also been involved in the analysis of MDI ancillary parts (such as spacers, O-rings, diaphragms and actuators) and routinely performs extractable and leachable studies by GC/MS, HPLC, etc.

Analysis of an MDI at Pace Analytical Life Sciences may involve, but is not limited to, the following:

  • Solution and Container Closure Appearance
  • Leak Rate
  • Valve Delivery
  • Impurity and Degradation Products by HPLC
  • Water Content
  • Foreign Particulate
  • Alcohol Content Assay
  • Uniformity of Delivered Dose
  • Number of Deliveries
  • Particle Size Distribution (Anderson Cascade Impactor)
  • Through-Life Delivery
  • Content Assay
  • Fill Weight
  • Identification
  • Microscopic Evaluation

Transdermal Drug Delivery (TDD) Testing

Pace Analytical Life Sciences specializes in the testing of complex drug delivery systems, including transdermal drug delivery (TDD) systems. For over 10 years, Pace Analytical Life Sciences has provided method development, validation and sample analysis services to the TDD industry.

Analysis of a TDD patch system at Pace Analytical Life Sciences may involve, but is not limited to, the following:

  • Release Rate Testing to evaluate in-vitro drug release characteristics using dissolution apparatus.
  • Content/Content Uniformity Testing to quantify the active pharmaceutical ingredient (API).
  • Testing by HPLC and TLC to provide impurity and degradation profiles.
  • Residual Solvents Testing to provide residual solvent levels.

ICH Stability Storage and Testing

Pace Analytical Life Sciences can offer long- and short-term (accelerated) stability storage services for a variety of dosage forms in your cGMP programs. Pace Analytical Life Sciences can provide you with stability protocols and analysis of samples using methodologies developed by Pace Analytical Life Sciences or your own scientific team. Stability reports can be tailored to meet your needs.

Dedicated Stability Personnel maintain Sample Receipt, Log-In, and Chain of Custody. All stability chambers are fully mapped and continuously monitored by a validated computerized (Datatron) monitoring system with external back-up power.

Contact Pace Analytical Life Sciences to discuss your current stability and storage testing needs. You can also request a quote online.

Additional Expertise

Pace Analytical Life Sciences also offers precisely designed and implemented protocols, protocol development, and customized method development and validation.

Contact Pace Analytical Life Sciences to discuss your current customized testing needs. You can also request a quote online.

Scope of Services for Combination Drug-Device Customers

Please visit the Scope of Services page for a full listing of available tests.