Blog Archive

September 16, 2024

Typical Autoclave Conditions for Sterilization

When you own or operate a pharmaceutical lab or cleanroom, your team needs to be aware of the typical conditions for autoclave sterilization, so you can adhere to industry best practices, following…
Read More

August 15, 2024

Cleanroom Cleaning Procedures

Why Proper Cleanroom Cleaning Is Crucial to Your Success When you operate a cleanroom, it's imperative to maintain strict standards of cleanliness in the facility at all times. Whether you work in…
Read More

August 15, 2024

Understanding ISO Cleanroom Cleanliness Levels: Maintaining Standards in Your Cleanroom

How clean is the air inside your cleanroom? By following industry best practices and adhering to ISO cleanroom standards, you have a better chance of avoiding the disruption and delays that…
Read More

July 26, 2024

Vaporized Hydrogen Peroxide Decontamination: An Effective Method for Decontamination of Facilities and Equipment.

Decontamination is a cornerstone of infection control in healthcare facilities, laboratories, or other spaces that may contain biological hazards. Ensuring that equipment and surfaces are free of…
Read More

July 26, 2024

Understanding Chemical Indicators for Sterilization & Decontamination: How They Work and Their Importance

Sterilization is a critical process in healthcare, laboratory settings, and various industries to ensure the elimination of all forms of microbial life, including bacteria, viruses, fungi, and spores…
Read More

March 13, 2024

ISO Class 7 Cleanroom Requirements

What Is an ISO Class 7 Cleanroom? An ISO Class 7 cleanroom is a controlled environment that adheres to specific cleanliness standards defined by the International Organization for Standardization (…
Read More

March 13, 2024

Air Change Rates And Maintaining Air Cleanliness

Cleanrooms or clean zones provide the necessary controls to reduce contaminants to a level appropriate for accomplishing contamination-sensitive processes. Cleanrooms or clean zones can be…
Read More

December 04, 2023

How To Improve BSL-3 Laboratory Performance

When you own and operate a Biosafety Level 3 facility, it’s crucial that all facility systems and equipment perform their functions as you intend. For example, it’s of utmost importance that the…
Read More

December 01, 2023

The MEP Commissioning Process for Biocontainment Laboratories

When preparing to work in Biosafety Level 3 (BSL-3) biocontainment facilities, your organization must adhere to biosafety guidelines, with a particular focus on mechanical, electrical, and plumbing (…
Read More

November 28, 2023

High-purity Water Testing – Where, When And How

Your company’s critical work to support cleanroom or laboratory applications depends on a reliable source of high-purity water. In pristine environments, such as pharmaceutical cleanrooms, you and…
Read More

November 28, 2023

Important Preventative Maintenance For High-purity Water Systems

In lab and cleanroom environments, high-purity water is essential for keeping operations going smoothly. The implication is that your organization must take seriously the importance of having a well-…
Read More

November 28, 2023

Types Of High-Purity Water In Labs

In laboratories and cleanroom settings, depending on the nature of the work you are doing, your operations will rely on different types of pure water. If you’re new to managing cleanroom…
Read More

November 01, 2023

What Is Computer System Validation In The Pharmaceutical Industry?

In the pharmaceutical industry, consistently ensuring the quality control of final products and compliance with regulatory requirements is of critical importance. One process that helps achieve this…
Read More

August 14, 2023

Understanding Lab Sterility Testing Methods

Sterility testing in lab settings helps to ensure that the proper conditions are in place for safe, accurate processes that meet industry standards and regulatory compliance requirements. These…
Read More

August 08, 2023

IMPORTANT LAB SAFETY EQUIPMENT

The critical work carried out in laboratory settings, especially labs for industries such as pharmaceutical, biotech, and other health- and medical-related fields, requires stringent safety processes…
Read More

August 04, 2023

Summary Of The USP <797> Updates

In November 2022, the United States Pharmacopeia (USP) announced updates to a number of chapters and guidelines, including USP <797>. After the 2022 announcement, these changes will become…
Read More

August 04, 2023

THE IMPORTANCE OF PARTICLE COUNTING IN LABS AND CLEANROOMS

Airborne particles in a controlled environment can have a significant negative impact on the integrity of the work performed and could even pose health risks. Airborne particle counting (AKA…
Read More

July 26, 2023

How To Approach Calibration Criteria

It is critical for equipment in laboratory settings to be properly calibrated in order to return reliable, repeatable results. Calibration helps to maintain accurate measurements, improve safety,…
Read More

July 11, 2023

High-Purity Water System Maintenance Guide

Water is used in nearly every aspect of laboratory processes, and it is critical that this water is of high purity — and in some cases, is essentially sterile — to produce safe, effective products…
Read More

June 13, 2023

SPECTROPHOTOMETER CALIBRATION AND MAINTENANCE

A spectrophotometer is one of the most common pieces of analytical equipment in a scientific laboratory. It measures the amount of light energy at specific portions of the spectrum as it passes…
Read More

June 13, 2023

Centrifuge Safety & Calibration

Centrifuges serve a critical purpose in laboratories, used to separate various components of samples for applications including purification, extraction of specific materials and concentration or…
Read More

June 06, 2023

Proper Biological Safety Cabinet Use

Biological safety cabinets (BSC) are critical equipment in laboratories to protect staff, research or samples, and the surrounding environment from contamination. These enclosed workspaces use…
Read More

June 05, 2023

Restricted Access Barrier Systems Explained

Pharmaceutical laboratories and manufacturing facilities have the ensure the cleanest, safest possible conditions to protect the public and their reputations. One of the most important elements found…
Read More

May 31, 2023

GUIDE TO LAB BALANCE CALIBRATION BASICS

Lab balance calibration is a critically important process in manufacturing settings, including pharmaceutical and medical products. Not only must daily calibration be performed to ensure accurate…
Read More

May 31, 2023

IQ OQ PQ FDA QUALIFICATIONS

The FDA takes qualification of lab equipment and validation of procedures very seriously in pharmaceutical and medical device research and manufacturing settings — and with good reason —failure to…
Read More

May 25, 2023

Quality Vendor Expectations

Too many of today’s vendors put profits ahead of service. By pushing multiple digital and automated self-service options, these vendors sacrifice service excellence, personalization and proactive…
Read More

May 24, 2023

Lab Freezer Validation Protocol

Freezer validation is an important process for pharmaceutical labs, medical manufacturing facilities and other life science and clinical markets where samples, drugs, raw materials and even vaccines…
Read More

May 11, 2023

BSL-3 Commissioning Requirements

Biosafety Level 3 (BSL-3) requirements apply to facilities that handle transmissible agents and toxins that can spread via the air and cause infection through respiratory inhalation. BSL-3 labs are…
Read More

October 31, 2022

Acceptable Cleanroom Materials

Keeping a cleanroom free from contamination requires attention to every last detail, including the materials that are allowed to be brought in and used in the cleanroom. Without a holistic, 360-…
Read More

October 12, 2022

Understanding HEPA Filter Pressure Trending And Why It Matters

High efficiency particulate air (HEPA) filters are an integral component of laboratory and cleanroom safety and integrity infrastructure. HEPA filter pressure measurements are one of the key factors…
Read More

October 12, 2022

The Importance Of Managing Cleanroom Air Exchanges Per Hour

Air exchange rate is a key term to understand in cleanroom construction, management, and maintenance. The air exchange rate for a cleanroom is defined as the number of changeovers of air within the…
Read More

September 28, 2022

Designing A Cleanroom Pressure Cascade

In cleanroom environments, control is critical, and air pressure is one of most important measures that must be closely monitored. Air pressure cascades are a highly effective way of controlling the…
Read More

June 27, 2022

How To Test Compressed Air Quality

Compressed air systems and compressed gas systems are one of the most critical utilities in a laboratory, food processing plant, cleanroom, or manufacturing environment.  It can supply power,…
Read More

June 27, 2022

Preparing For Pharmacy Certification

Sterile compounding pharmacies encounter some of the most highly critical and sensitive challenges in keeping the work environment safe and compliant. There are two pharmacy certification types that…
Read More

June 27, 2022

Surface Sampling Methods For Microbiology

Environmental testing in controlled spaces is the most effective way to detect the presence of micro-organisms, which can present significant health and safety risks, especially in cases of…
Read More

June 15, 2022

Surface Wipe Sampling For Hazardous Drugs

In settings where sterile and non-sterile hazardous drugs and materials are regularly handled, constant vigilance is necessary in the ongoing effort to keep personnel safe while controlling…
Read More

June 03, 2022

Bag-In/Bag-Out vs. Non-BIBO Systems

High efficiency air filters are used in various industries and for many purposes. One such application is to use high efficiency filters to remove hazardous/harmful matter from exhaust air before…
Read More

May 18, 2022

Viable Environmental Monitoring And Trending Data

Environmental monitoring (EM) and testing in laboratory settings are key components in operating a lab successfully and safely. In order to remain safe — and compliant with regulations — facilities…
Read More

May 17, 2022

Which Is Better: Analog Or Digital Pressure Gauge?

Pressure monitoring devices represent a fundamental component of key media transport processes, including gas and liquid systems in refineries, electrical plants, industrial facilities, and more.…
Read More

April 26, 2022

What Does the CETA Organization Do?

The primary objective of the CETA organization is to promote quality assurance in controlled environment testing and certification. CETA also exists to disseminate knowledge, information and data,…
Read More

April 01, 2022

The Importance Of Autoclave Calibration And Validation

An autoclave is one of the most powerful pieces of equipment in a laboratory setting, drawing on pressure and heat to rapidly sterilize critical equipment more quickly and effectively than nearly any…
Read More

April 01, 2022

Understanding 'As Found' And 'As Left' Calibration Data And Its Importance

Accuracy and reliability are of great importance for lab equipment. For this reason, lab equipment must be calibrated on a regular basis — anywhere from monthly to yearly — in order to remain in spec…
Read More

March 22, 2022

Tips For Maintenance Of Laboratory Equipment

Most laboratories contain sophisticated equipment required to complete work with accurate, reliable, and repeatable results. Most of this equipment requires some form of maintenance or checks to keep…
Read More

March 17, 2022

Critical Aspects of TSS’ Certifications

Third-party certifications, whether company-wide or for individual employees, provide a differentiator, a competitive edge, and an assurance to which process and quality standards are consistently…
Read More

March 14, 2022

Biotechnology Cleanroom Considerations

Biotechnology is one of the most innovative areas in science today, focusing on all areas of life sciences: medicine, the environment, agriculture, the animal world, and more. These areas of…
Read More

February 16, 2022

How Often Should Test Equipment Be Calibrated?

The reality of using any type of equipment is that over time it will drift out of calibration. This is an understood and generally accepted part of owning and operating laboratory and other…
Read More

February 10, 2022

Cleanroom Protocols And Guidelines

Safety is paramount in the cleanroom, especially for those working in particularly hazardous environments and testing rooms. The best safeguards against unexpected incidents, emergencies and…
Read More

February 03, 2022

What Is Bioburden And Why Is It Critical To Assess It?

In the medical device manufacturing industry, proper sterilization is among the most critical steps in better ensuring the safety of the product for its end users. Since these devices are often in…
Read More

January 23, 2022

Use Of An Unidirectional-Flow, Clean Air Device (a.k.a. Clean Beach)

  Rooms, or secondary engineering controls, are designed to mitigate contamination issues with samples or products, but sometimes a part of the process requires an additional level of…
Read More

January 20, 2022

Cleanroom Gowning Guide

In cleanroom settings, it is necessary to follow the proper protocols to maintain the integrity of the cleanroom and prevent contaminants from entering the controlled environment. Proper cleanroom…
Read More

January 18, 2022

The Importance Of Gloved Fingertip Sampling

Gloved fingertip sampling is a key test assessing the aseptic technique of compounding personnel. The gloved fingertip test assesses the amount of microbial contamination present on workers’ gloved…
Read More

October 25, 2021

How To Start A Cleanroom

Many professionals involved in the research and development of cutting-edge technologies are familiar with the importance of cleanrooms. Whether you use yours for R&D, manufacturing or some other…
Read More

October 23, 2021

How To Properly Set Up A Testing Lab Facility

Setting up a testing laboratory is a significant project, but it doesn’t have to be a daunting one. In this post, we’ll discuss types of test labs as well as the equipment and logistics that are part…
Read More

October 19, 2021

Commissioning A Lab: Why And How It's Done

The processes of building, opening or renovating a laboratory facility are unlike similar processes for just about any other application. While other kinds of facilities are typically planned,…
Read More

October 13, 2021

GMP Documentation Guidelines

What is GMP documentation? As a component of Good Manufacturing Practices, GMP documentation ensures the quality and traceability of manufacturing processes, maintenance and quality checks. The…
Read More

October 01, 2021

How To Avoid Contamination In A Lab

In a laboratory setting, contamination can wreak havoc in nearly every aspect of the operation — resulting in shutdown, cleaning, testing time, risk to personnel, skewed lab results, unusable…
Read More

September 02, 2021

How Often Should Biological Safety Cabinets Be Certified?

Biological safety cabinets are one of the primary safety measures in any laboratory setting that deal with microbes and infections agents. These secure, ventilated enclosures ensure that when…
Read More

September 01, 2021

The “Just Right” Guide to PEC Pressure Gauges

The pressure gauges installed onto primary engineering controls (PEC, such as biosafety cabinets or clean benches) aid in the assessment of proper function and troubleshooting when utilized properly…
Read More

August 24, 2021

Guide To Cleanroom Classifications: Understanding The Basics

  Cleanrooms are used for the manufacture, testing and design of products in health- and safety-critical fields such as medical device manufacturing, pharmaceuticals, food and beverage, aerospace,…
Read More

July 06, 2021

Fume Hood Testing Procedure: Outlining The Basics

Fume hoods are designed to protect people who work with chemicals that may produce hazardous gases, vapors and particulates. They achieve this with airflow that pulls dust and fumes away from where…
Read More

June 14, 2021

8 Tips for Hazardous Chemical Handling In A Lab

Laboratory work with chemicals is a necessary component of a wide range of fields and industries: the medical field, pharmaceuticals, cosmetics, industrial applications, consumer products and many…
Read More

February 23, 2021

Why Endotoxin Testing Is Critical

Companies in the pharmaceutical and food industries must operate with extreme care to prevent their products from causing more harm than good. One of the most insidious threats these businesses must…
Read More

February 18, 2021

What Is Water For Injection?

Life as we know it on Earth would not exist without water. Not only is it one of the critical building blocks that make up the cellular structure of all living things, but it also serves virtually…
Read More

December 15, 2020

What Is Media Fill Testing?

Media fill testing is the method of assessing the technique and competency of personnel who manipulate and create compounded sterile preparations. To maintain the purity of samples, compounds and…
Read More

December 06, 2020

Considerations for Annual Cleanroom Shutdowns

Cleanroom shutdown events occur for numerous reasons, planned and unplanned. In returning to normal operation, there are key best practices that can be followed for a successful return to normal…
Read More

September 09, 2020

What Is ASHRAE 110?

Chemical fume hoods are an integral part of laboratory safety, and a malfunctioning hood could prove disastrous to workers interacting with dangerous chemicals and fumes. A trade organization called…
Read More

July 10, 2020

Understanding Purity And The Types Of Water Used In A Laboratory

No matter what type of work is done in a laboratory, it’s almost certain that lab water is required to carry out certain processes. Due to the sensitive nature of laboratory work — and the need for…
Read More

June 03, 2020

What Is Autoclave Sterilization?

What is autoclave sterilization? The simplest explanation is that it is a highly effective method of sterilizing and disinfecting objects through the use of heat — in the form of steam — plus…
Read More

June 02, 2020

The Importance Of Testing Lab Safety

Professionals in industries such as medical device manufacturing, biotechnology, healthcare, pharmaceuticals, nanotechnology and more are conducting some of the most vital work in testing labs.…
Read More

April 26, 2020

Lab Decontamination Challenges

If you are planning to reopen a lab after the Covid-19 crisis, please contact us and we are happy to help. Lab decontamination is an important responsibility that comes as part of lab occupancy.…
Read More

February 06, 2020

What To Consider When Relocating Your Laboratory

Moving is seldom a stress-free process. That’s especially true when attempting to relocate a laboratory. While moving the contents of your home may be challenging enough, relocating a laboratory —…
Read More

January 30, 2020

How To Close A Laboratory Facility

Running a safe, compliant laboratory can be challenging enough. But what if you need to quickly learn how to close a lab? Decommissioning a working laboratory is far from simple. Numerous factors…
Read More

January 20, 2020

TSS Decommissioning Services

TSS is a marketplace leader providing comprehensive decommissioning, decontamination, lab closure, and relocation services to mitigate liability and assure compliance. Our team of Project Managers,…
Read More

January 13, 2020

Large Scale Decontaminations

Large scale decontaminations may be required for many different reasons – for example, a planned lab shutdown may include a space decontamination to facilitate planned maintenance, or an unplanned…
Read More

December 31, 2019

Viable Environmental Monitoring

Viable environmental monitoring provides critical information towards understanding the relative cleanliness of the sampled environment. Typically, viable airborne and surface data is collected to…
Read More

December 11, 2019

Quality for Service Providers

How would you define a high-quality testing service? Quality means conformance to requirements; and the requirements are dependent on the related industry. This makes quality a subjective concept as…
Read More

November 13, 2019

HEPA FILTER INTEGRITY TESTING – CONSIDERATIONS IN HEPA FILTER PORTS

HEPA filters are sold in a variety of models and configurations, including with or without injection and testing ports. As HEPA filter leak testing involves upstream challenge of the HEPA filter with…
Read More

October 04, 2019

USP <795>, <797>, and <825> Postponed

  USP has postponed the official dates of the below chapters from December 1, 2019 until further notice: · <795>: Pharmaceutical Compounding – Nonsterile Preparations · <797>:…
Read More

September 30, 2019

CDA (ISO 8573) - Why Test?

Why test CDA or CGS systems? Compressed dry air or compressed gas systems are critical utilities in your clean environments. CDA or CGS systems may be used in process applications directly or…
Read More

September 06, 2019

Validation: Temperature Controlled Units

Validation of temperature-controlled chambers is a critical component of a robust process and/or facility qualification plan. Validation includes Installation Qualification (IQ), Operational…
Read More

August 20, 2019

2019 Updates to USP <797> and how TSS is responding

USP <797> lays the foundation of standards for compounding sterile preparations. According to USP, “…<797> helps to ensure patients receive quality preparations that are free from…
Read More

August 06, 2019

Welcome to our blog!

Here at Technical Safety Services we are dedicated to the highest quality of compliance and safety for our clients, their processes and the people they serve.  Our services are used by over 11,…
Read More

Return to Blog