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Container Closure Integrity Testing
--Sign Up For Newsletter
--Method Development And Validation
--Personal Care Chemistry Testing
--Anaytical Gas Testing
--CONTAINER CLOSURE INTEGRITY
--Vacuum Decay Leak Detection
--Electrical Conductivity (HVLD)
--Helium Leak Testing (HeLD)
--Residual Seal Force (RSF)
--Mass Flow Leak Detection
--USP 660 Pharmaceutical Glass Testing
--USP 661 Plastic Containers Testing
--USP 670 Auxiliary Packaging Components
--USP 671 Container Performance Testing
--EP & JP Container Testing
--Elastomeric Closure Testing
--Biological Reactivity Testing
--Container Qualification Full Test List
--Drug Delivery Device Testing
--Dose Delivery Testing
--Mechanical and Functional Testing
--Extractables and Leachables
--E&L for Pharma/Biotech
--Medical Device Testing
--ISO 10993 Biocompatibility
--ISO 11607 Validation
--Device Mechanical and Functional
--Microbial Limits Test
--Bacterial Endotoxin Testing: USP <85>
--Antimicrobial Effectiveness Testing (AET)
--Microbiological Population Verification
--USP<87> Biological Reactivity Tests – In-Vitro
--Disinfectant Efficacy Testing
--DISTRIBUTION AND PACKAGE TESTING
--ASTM & ISTA Distribution Testing
--Environmental Cycling And Simulation Testing
--Pharmacuetical Package Testing
--Medical Device Packaging Testing
--Consumer Product Testing
--Shelf Life & Accelerated Aging Testing
--Packaging Materials Testing
--Package Integrity Testing
--Package Strength Testing
--Package Labeling Testing
--Retains and Complaint Resolution
BlogCategory: Technical Services
The Accumulative Effect Of The Transport Environment (Part 6)
In package performance protocols, these vibration forces are incorporated into a regimen of other transport hazards such as handling (shock), compression, and environmental temperature and humidity extremes.
Part 5 - Vibration Testing - What test to Use?
ASTM D 4169-14 is the current FDA approved consensus standard. The typical test regimen for medical device package testing is distribution cycle 13 (DC 13). The test intensity levels are most co
What may cause difficulty for MDM’s in vibration testing and performance testing programs
The debate in the industry is which standard to use for compliance with the ISO 11607 standard.
Medical Device Package Performance - Vibration Testing (Part 3)
Significant product and package responses and interactions during shipment can be severe and may lead to package or product failure. Identification of critical frequencies and the nature of package stresses can aid in minimizing the effect of these occurrences.
Vibration Testing in the Medical Device Industry
Is critical in the package development and design process to assess the ability of the sterile barrier system to resist the vibratory forces in the transport environment
Vibration and its Damaging Effects?
The nebulous aspect of vibration is that most of the damage caused by vibration forces is not known to have occurred until the product is delivered and about to be used for its intended use.
How clean is clean? - Cleaning, sanitizing, decontaminating… are you at par with FDA guidelines?
Modern cleaning validation procedures must be implemented to prove that the equipment is reasonably free of any residue. It must be documented to be safe, causes no product quality concerns, and the process is contaminant-free in accordance with FDA, cGMPs, and USP guidelines.
FDA Guidance on Method Validation – Part One
Method Validation effects the development and quality control testing of most products. Updated FDA guidance titled Analytical Procedures and Methods Validation for Drugs and Biologics
A Candid Look at the Contract Pharma Conference
A few months back I published a blog article on the value of attending Interphex. For the regular readers (I know there are few), you will recall that I started that article by simply stating my dista
Residual Solvents: Most Difficult and Demanding Test in the Pharmaceutical Industry
Pharmaceutical products should contain low levels of residual solvents as determined by safety data. The presence of residual solvents in pharmaceutical products needs to be determined through testing
Effective Teamwork in a GMP Laboratory Environment
Three years ago, the executive management of Whitehouse Laboratories implemented a major reorganization plan. Over the previous ten years, the company had experienced many areas of growth to include e
Navigating USP Updates
Available tools to navigate the USP flow of information that will help remain abreast of changes that may affect your organization
The Value of Pharmaceutical, Biotechnology and Science Related Internship Programs
implementing an intern program for college students specific to engineers, chemistry, biology and material science students can lead to a mutually rewarding results
The Strategic Use of Outsourcing
Contract laboratories go beyond routine laboratory work and provide the consultancy support required to meet theses ever changing regulatory developments.
Defining Technical Services
Technical Services division performs testing in key service areas such as, Unit Dose, Mechanical Testing, Stability. Cleaning Validation, Extractable Leachable.
The Value of Attending the Interphex Conference
Three key observations as to why Interphex is a must attend event. Interphex will bring over 12,000 global pharmaceutical and biotechnology professionals together in New York
Qualifying “Excipient” Gases (Nitrogen, Carbon Dioxide, Oxygen) In the Drug Manufacturing Process
Qualifying Excipient Gases In the Drug Manufacturing Process. Steps to minimize and eradicate the possibility for the introduction of contaminated substances
Considerations When Choosing a Partner for Medical Device or Package Testing
In a recent article, we reviewed and discussed key components of cGMP and ISO 17025 quality systems and the role they play in the world of contract laboratory testing as it relates to pharmaceutical,
The Value of ISO 17025 and cGMP Quality System Standards
Key areas to focus on when qualifying an outsourcing partner are Good Manufacturing Practices (GMP), and ISO 17025 quality standards.
An Overview of ISO 11607 Testing
Key components to the ISO 11607 procedure. ISO 11607 is the principle guidance for validating terminally sterilized medical device packaging
Are You Qualifying Your Dose Cups?
The Proper Approach to Volume Verification Testing of Metered Drug Delivery Devices
Stability Testing – Overview and Update
Stability testing and monitoring in the drug development and manufacturing process. A critical step applicable to Food and Drug Administration (FDA) regulated products.
Syringe Qualification Testing
The USP 661 and USP 671 general chapters are effective in outlining the test requirements for a plastic container and a package system.
Container Closure Integrity Testing (18)
Container Testing (17)
Extractable Leachable (1)
Materials Testing (15)
Package Testing (21)
Technical Services (23)