Pine Lake Laboratories.
Challenges Today. Solutions Tomorrow.

Working with clients to assist in bringing innovative, safe new medicines and medical devices to patients in need.

GET A QUOTE

Ask a Question

Our team of experts are waiting to hear from you.
Pine Lake Laboratories is here to help.

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Technical Library

Subscribe to our white papers to get the industries latest news.

Managing the Risk of Leachables from Container Closure Systems: Part One

View & Download Pine Lakes Lab Presentation On Managing the Risk of Leachables from Container Closure Systems

Read More

Implementing an Effective Business Continuity Plan at the Contract Laboratory

Why are you writing a Business Continuity Plan (BCP)?

In our case, a client auditor reviewing our quality systems for cGMP compliance noted that while we had SOPs in place on Disaster Recovery, Backup Power Generation, Preservation of Raw Data, Safety and others to deal with adverse events that can disrupt the business of the laboratory, we did not have a formal BCP. It was to meet our client’s expectations, not to comply with the cGMPs, GLPs or ISO standards, that we wrote the BCP.

In the process, we learned that the BCP, to be more than a document, has to be part of a Businesvs Continuity Management (BCM) system. The BCM system supports the plan and fosters its continual improvement.

Read More

Cleaning Validation for Medical Devices Exposed to a Large Number of Processing Agents

During manufacturing, medical devices are exposed to a wide range of processing agents and materials. Depending upon the medical device, residual levels of these processing agents and materials pose a potential toxicological risk to patients. Therefore manufacturers of medical devices need to identify and properly control for contamination of the medical device from processing agents and materials encountered during the manufacturing of the device. This is done by validation of the cleaning of the medical device.

Please Fill Out Form To Receive The Full White Page Download.

Read More

Analytical Methods Single Entity Combination Products

The demand for sophisticated drug delivery has led to the development of many innovative combinations of pharmaceuticals, biologics and medical devices across a broad range of therapeutic areas. While these combination products have the potential to fulfill major unmet medical needs, they also present unique challenges in development and approval. One of these challenges is the development and validation of analytical methods to assess the quality, safety and stability of combination products.    This white paper will focus on the analytical methods needed for single entity combination products.

Read More

Extractables and Leachables for Medical Devices Meeting The 510K Requirements

Recent changes in the FDA’s 510(k) requirements for medical device applications have spawned many inquiries from clients on how to address the request for extractables, leachables and drug compatibility data.  Meeting the expectations of the CDRH can be challenging in that any given study design is not universally applicable to all devices.  A good study design requires elements of the best practices documented in ISO-10993-12, the PQRI guidance for E&L testing of OINDP as well as any specific requests for drug compatibility data from CDRH.

A hybridized study design, incorporating the essential regulatory elements, has been developed and successfully implemented for a variety of medical device applications.  The rationale behind selection of the elements, overall experimental design strategy and interpretation of the resulting data will be presented.

Read More

Pharmaceutical Extractable and Leachable Studies

Leachables from sample container closure systems from primary and secondary packaging component that migrate into a drug products have a potentially negative impact on safety.  This white paper describes how to evaluate this risk through the proper design of an extraction study and the following analysis of leachables in the drug product.

Read More
Request a QuoteHave a Question?