Taryag Laboratories

Transportation testing, also known as distribution simulation, is a key validation requirement for sterile medical devices and involves applying the same forces and conditions on a packaging system commonly seen in real-world transit. Taryag offers both single shipping unit and pallet transportation tests.

The testing of particulate matter encompasses a series of measures aimed at eliminating, tallying, and gauging particulate impurities found in injections, parental infusions, ophthalmic solutions, and diverse medical devices.

This test serves the purpose of assessing the quantity of particulate matter naturally present in a product, as well as identifying the extent of particulate matter originating from the manufacturing process. Through simulated use testing, it is also possible to determine the extent of particulate matter released during device operation.

To meet the ISO 10993-7 standard, any medical device sterilized by ethylene oxide (EO) for human use must undergo residual testing to determine EO residual levels, which can be harmful to the end-user or patient. The limits set by ISO 10993-7 vary according to the intended use of the device, and there are three main categories a device may fall under: limited use, prolonged use, and permanent use. In addition, there are several special device categories that have their own unique set of limits.

In particular, devices considered surface-contacting or implantable must meet an additional set of criteria called the tolerable contact limit (TCL). The purpose of this standard is to prevent localized irritation due to the release of ethylene oxide (EO) or ethylene chlorohydrin (ECH).

Environmental testing is performed to detect packaging problems that could adversely affect the sterility of a medical device. As part of the test, sterile products are subjected to environmental stress intended to simulate extreme conditions that a product might encounter in shipping or storage. The product packaging is then put through a set of tests to determine if it has retained the ability to serve as a microbial barrier.

Bioburden testing involves measuring microbial contamination levels on or in a product. Many single-use medical devices are terminally sterilized using EO, steam, or radiation technologies, and medical device manufacturers are required to validate the sterilization process through bioburden testing. Bioburden testing is also performed on devices as part of routine quality control.

LAL (Limulus Amebocyte Lysate) testing, also known as bacterial endotoxin testing, is an in-vitro procedure used to detect the presence and concentration of bacterial endotoxins in drugs and biological products. Endotoxins, a type of pyrogen (fever-inducing substance), are lipopolysaccharides present in the cell walls of gram-negative bacteria that can prove harmful or even fatal when introduced to humans above certain concentrations. At Taryag, LAL tests are performed in around 20 minutes, facilitating speedy product distribution.

Conducted by direct inoculation or membrane filtration methods in a clean room environment, sterility testing is required to ensure viable contaminating microorganisms are not present in a product.

Biological indicator testing involves adding indicator strips to products before the validation process to assess how well the product bioburden is controlled by the chosen sterilization method. The test is also applied during routine monitoring for product release.

Taryag’s Laboratories provide biological indicator testing for a range of sterilization methods, including steam, radiation, and ethylene oxide (EO).

As spores are usually challenging to sterilize, their presence/absence in the final sample validates the method or lot and determines sterility assurance levels (SALs)

Taryag offers method development and validation in accordance with the relevant regulator requirements for pharmaceuticals, medical devices, and related industries.

Method Development

While method development can be complex, Taryag designed systematic procedures to guide our customers through the process. Our team is experienced in developing methods for drug products, APIs, and excipients, as well as healthcare products and cosmetics, while our laboratories are equipped to perform method development studies. We also offer acid, base, peroxide, light, and temperature-forced degradation, which are essential in developing stability-indicating methods.

Method Validation

After a successful method development, its efficacy must be validated. Taryag performs method validation studies per ICH guidelines, starting with preparing a validation protocol, which is shared with our clients for approval. After the protocol is approved, the study begins, and the following parameters are tested regularly: specificity, limits of detection and quantification, linearity, accuracy, precision, and robustness. Upon the study’s conclusion, all results are presented to the customer in a validation report.

High-Performance Liquid Chromatography (HPLC) is a medical device testing technique that involves the separation and analysis of components within a liquid sample to determine their purity and composition. HPLC utilizes a high-pressure system with a stationary phase material and a mobile phase (solvent) to separate the sample’s constituents. By measuring their interaction with the stationary phase, different components are separated and detected using specialized detectors. HPLC enables the identification of active pharmaceutical ingredients (APIs), identification of impurities, assessment of degradation products, and analysis of various substances present in medical devices.

Small molecule identification and purity tests are crucial requirements for lot releases. Taryag’s Laboratory leverages multiple testing methods to ensure that final pharmaceutical products match client specifications. Infrared spectroscopy is notably the most powerful test in confirming the identity of small molecules and compounds..