Cleanroom Blog and Recent News
The impact of Artificial Intelligence on GMP industries
The manufacturing landscape has been significantly transformed over the past few decades, with the advent of cutting-edge technologies like Artificial Intelligence (AI). Among the various sectors benefiting from AI integration, Good Manufacturing Practices (GMP) industries have experienced a profoun...
Tue Sep 12 2023
The Competitive Edge: Why Top Pharmaceutical Manufacturers Rely on Outsourced Cleaning
The Competitive Edge: Why Top Pharmaceutical Manufacturers Rely on Outsourced Cleaning In the highly competitive world of pharmaceutical manufacturing, every advantage counts. To stay ahead of the curve, top pharmaceutical manufacturers are turning to outsourced cleaning services to gain a competi...
Wed Aug 16 2023
The 5 W's of Outsourcing: Exploring the Who, What, When, Where, and Why of Cleanroom Cleaning
Outsourcing cleanroom cleaning services is a common practice in the pharmaceutical, biotech, and medical device industries. It allows companies to focus on their core competencies while ensuring that their facilities are maintained to the highest possible standards. However, before deciding to outso...
Mon Jul 31 2023
CDMOs and the Advantages of Outsourcing Cleaning to Industry Experts
In the pharmaceutical industry, contract development and manufacturing organizations (CDMOs) play an important role in bringing drugs and medical devices to market. However, running a successful CDMO requires a great deal of expertise, attention to detail, and strict adherence to Good Manufacturing ...
Wed Jul 26 2023
The Role of QMS (Quality Management System) in GMP Compliance
In the pharmaceutical and biotech industries, Good Manufacturing Practices (GMP) are the foundation of ensuring product safety, efficacy, and quality. A Quality Management System (QMS) is an essential element of GMP compliance that encompasses the processes, procedures, and resources required to ens...
Tue Jul 18 2023
Understanding the FDA's Current GMP Regulations and Guidelines
The Food and Drug Administration (FDA) is responsible for ensuring that all pharmaceuticals, biologics, and medical devices that enter the market are safe, effective, and of high quality. To ensure this, the FDA has established a set of guidelines and regulations for the manufacturing, processing, p...
Thu Jul 06 2023
GMP for Clinical Trials: Overview and Requirements
Good Manufacturing Practices (GMP) is an essential part of any pharmaceutical manufacturing process. When it comes to clinical trials, GMP ensures that the investigational product is produced to the highest quality standards, which in turn helps to ensure the safety and efficacy of the product. In t...
Thu Jun 22 2023
GMP Auditing: Best Practices and Common Pitfalls
Good Manufacturing Practices (GMP) auditing is a critical aspect of maintaining compliance with regulatory requirements and ensuring product quality and safety. However, it can be a complex and challenging process for companies to navigate, particularly when it comes to identifying and addressing co...
Tue Jun 20 2023
GMP Documentation: Best Practices and Requirements
Good Manufacturing Practice (GMP) documentation is essential for ensuring the quality, safety, and efficacy of pharmaceutical products. GMP documentation serves as a record of all activities involved in the manufacturing process and provides a means to ensure that procedures are followed consistentl...
Wed Jun 14 2023
Data Integrity
Data integrity is a critical aspect of Good Manufacturing Practice (GMP) compliance in the pharmaceutical industry. GMP is a set of guidelines that ensure pharmaceutical products are consistently produced and controlled to meet quality standards. In recent years, data integrity has become an increas...
Fri Jun 09 2023
Risk Management
Risk management is a vital component of good manufacturing practice (GMP) compliance in the pharmaceutical industry. GMP regulations require pharmaceutical companies to implement a risk-based approach to the identification, evaluation, and control of risks associated with the manufacture of their pr...
Tue Jun 06 2023
Quality Control
Quality control is an essential aspect of good manufacturing practice (GMP) compliance. GMP compliance is crucial for ensuring that pharmaceutical products are safe, effective, and of high quality. The primary goal of quality control is to ensure that pharmaceutical products meet the specified quali...
Thu Jun 01 2023
Sterilization Methods
Sterilization of medical devices is a critical aspect of ensuring the safety and efficacy of medical procedures. A wide range of medical devices are used in healthcare, including surgical instruments, implants, catheters, and many others. These devices need to be free from any microorganisms that ma...
Mon May 29 2023
The Role of HEPA Filters in Cleanrooms
HEPA (High-Efficiency Particulate Air) filters are an essential component of cleanroom design. HEPA filters are designed to remove particles as small as 0.3 microns with an efficiency of 99.97%. HEPA filters are critical for maintaining the required level of cleanliness in cleanrooms. Here are some ...
Wed May 24 2023
HVAC Systems in Cleanrooms: Design and Performance Requirements
HVAC (heating, ventilation, and air conditioning) systems are critical components of cleanroom design. HVAC systems in cleanrooms must maintain the required level of cleanliness, temperature, humidity, and air pressure to ensure a sterile and contaminant-free environment. HVAC system design and perf...
Fri May 19 2023
Cleanroom Design: Requirements and Best Practices
Cleanroom design is a critical component of maintaining a sterile and contaminant-free environment. The design of a cleanroom is essential to ensure that the required level of cleanliness is achieved and maintained. Cleanroom design requirements and best practices vary depending on the industry and ...
Tue May 16 2023
Types of Cleanrooms: Classification and Applications
Cleanrooms are highly controlled environments used in various industries such as pharmaceuticals, biotechnology, microelectronics, and healthcare to maintain a sterile and contaminant-free environment. Cleanrooms are classified based on the level of cleanliness required for specific applications. Th...
Thu May 11 2023
Maintaining a Cleanroom Environment: Best Practices for Contamination Control
Cleanroom environments are essential for various industries such as pharmaceuticals, biotechnology, microelectronics, and healthcare to ensure product quality and safety. Contamination in a cleanroom can have severe consequences, including product recalls, equipment damage, and even life-threatening...
Mon May 08 2023
Contamination Control in Cleanrooms: Key Elements
Cleanrooms are specialized environments that are designed to maintain low levels of particulate and microbial contamination. These environments are critical in many industries, including pharmaceuticals, biotechnology, and electronics manufacturing. Contamination control is essential to ensure produ...
Wed May 03 2023
Vibraclean - Your Partner for Controlled Environments
Vibraclean: Your Trusted Partner for Cleanroom Maintenance and GMP Consulting When it comes to maintaining the sterility of cleanrooms and critical environments, there's no room for error. That's where Vibraclean comes in. Founded in 1988, Vibraclean is a leading GMP consulting group and service pr...
Tue May 02 2023
Sterility Testing
Sterility testing is a critical component of pharmaceutical manufacturing. It is a process used to ensure that pharmaceutical products are free from any viable microorganisms, such as bacteria, fungi, and viruses, that may cause infection or harm to patients. The failure to perform proper sterility ...
Fri Apr 28 2023
Environmental Monitoring for Cleanrooms: Strategies for Effective Control
Cleanrooms are critical environments for many industries, including pharmaceuticals, biotech, and electronics manufacturing. These environments require stringent control of particulate and microbial contamination to ensure product quality, safety, and efficacy. One essential aspect of maintaining th...
Tue Apr 25 2023
Why Contamination Control is Important
Contamination control is a critical aspect of cleanroom operations in GMP facilities. A cleanroom environment must be maintained at a level that is free of contaminants, which could compromise the integrity of the products being manufactured. Best practices for contamination control in cleanrooms a...
Thu Apr 20 2023
Types of Cleanroom and GMP Contamination
Cleanrooms and GMP facilities are designed to manufacture products that require a controlled environment, free from contaminants that can compromise product quality and safety. The products manufactured in these facilities are typically pharmaceuticals, biologics, medical devices, and other high-val...
Mon Apr 17 2023
Key Principles of Contamination Control
Contamination control is a critical aspect of cleanroom operations in the pharmaceutical, biotechnology, and medical device industries. Cleanrooms and GMP facilities are designed to control and minimize the introduction, generation, and spread of contaminants that can compromise the integrity of the...
Wed Apr 12 2023
Clean Room Services, Decontamination and Biological Indicators (BIs)
What is a BI? Vibraclean has over 30 years experience in decontamination services and GMP services in canada, cleaning rooms and biological sterilization is our expertise! A biological indicator is broadly defined as a characterized preparation of a specific microorganism that provides a defined and...
Thu Dec 08 2022
How to use and validate iHP Cycles
Ionized Hydrogen Peroxide (iHP) iHP is hydrogen peroxide which is split into reactive oxygen species (ROS) by Binary Ionization Technology (BIT) that increases the efficacy and effectiveness of its use as a disinfectant. iHP is also classified as a sterilant, meaning that it can achieve sterilizatio...
Thu Dec 08 2022
Manual Sporicide vs. iHP: A Comparison
Vibraclean has 30 years working to eliminate and sterilize cleanroom facilities across Canada and the US. In this article we will explore the best approach and guidelines to dealing with biological sterilization of spores and bacteria offering the most effective and trustworthy decontamination and f...
Thu Dec 08 2022
Overview Hydrogen Peroxide Fogging
Hydrogen Peroxide Fogging is a method of decontamination that releases aerosolized hydrogen peroxide into enclosed areas. Because of its ability to work on a molecular level, hydrogen peroxide fogging is a much more efficient and effective way of eliminating microbes than manual cleaning. Aerosolize...
Wed Dec 07 2022
Fogging with iHP, VHP or HPV
It is important to identify the different hydrogen peroxide systems that are in use today, the different abbreviations associated with each and to highlight the differences between them. VHP refers to vaporised hydrogen peroxide and is a trademark of Steris who were one of the original pioneers in h...
Wed Dec 07 2022