Aug 12, 2020 | Leading-Edge Equipment
Thermal Mapping or Thermal Validation is the method of validating or qualifying equipment and storage facilities, e.g., warehouses, storage facilities, refrigerators, freezers, incubators, cryo-apparatus, autoclaves, depyrogenation ovens and tunnels, lyophilizers, photostability chambers, SIP systems, etc., that you claim will maintain a defined temperature range or profile during their intended use and operation. Thermal mapping determines if the facility or equipment will maintain the temperature range you claim under your actual conditions of use.
If you are in the pharmaceutical, biotechnology, or healthcare industries, you need to have properly maintained, calibrated, and validated equipment and facilities, not just for regulatory compliance but for reliable and profitable operations. You need to do thermal mapping of your temperature controlled equipment.
What are the tests performed during thermal mapping?
You want to do a risk assessment before you do the thermal mapping so you can identify all of the tests you need to do based on your risks. You identify the required tests for your thermal validation study based on your risk assessment.
Common tests for refrigerators, freezers, and incubators include
- Temperature Distribution Test (Empty Chamber)
- Temperature Distribution Test (Loaded Chamber)
- Pull-down Tests
- Door Open Tests
- Power Loss Tests
- Alarm Tests
- Recovery Time Tests
Common tests for Autoclaves, Dry Heat Ovens, Depyrogenation Lines, Pasteurizers, etc., include
- Temperature Distribution Test (Partial Load)
- Temperature Penetration Test (Loaded)
- Pull Down Tests
- Accumulated Lethality (Fo and FH) Tests
Other tests to consider based on your risk assessment include
- Compressor Switch Over Tests
- Compressor Failure Tests
- Fan Failure Tests
- Emergency Generator Cutover Tests
- Routine Use Tests
How is Thermal Mapping done?
Thermal mapping involves the placement of an array of pre-calibrated temperature, temperature and humidity, or temperature and other parameter data-logging sensors in pre-defined locations within the enclosed space or the equipment. You start the data-logging sensors and run the tests specified in your approved thermal validation study protocol. You want to run the thermal validation study long enough to go through the planned defrost cycles for your equipment. If you are mapping warehouses or facilities, you may want to consider mapping studies in both a hot, dry summer month and in a cold, wet winter month to show that no matter what the weather conditions your facility meets your specifications. After the thermal mapping study, the sensors are post-calibrated to assure that the sensors are still operating as you expect.
How long does thermal mapping take?
A thermal mapping study takes one to two weeks, including the time to prepare and approve the protocol, pre-calibrate the sensors, the actual testing, and the post-calibration of the sensors. Typical thermal mapping study execution times are in these ranges.
- Temperature-controlled units (run duration or 24-72 Hours)
- Warehouse/Dry Storage Facility (1 Week)
- Cold Storage (24 Hours to 1 Week)
Results
The thermal mapping output is temperature (and other parameters) versus time report at each location. The thermal map is a temperature (and other parameter) data plot for each location over time. The final study report demonstrates that your equipment or facility can meet your specifications when you operate it as you intend to operate it.
PSC Biotech is the right thermal mapping service
If you need thermal mapping services, calibration services, and state-of-the-art wireless or wired equipment to do thermal mapping validation of your equipment and/or facility, contact PSC Biotech. Our thermal mapping experience and supply of calibrated state-of-the-art wireless and wired sensors can meet all your needs for thermal mapping.
Aug 6, 2020 | Consultant Tells All
DATA SCIENCE IN THE LIFE SCIENCE INDUSTRY
Life sciences companies have only in recent years begun the switch from information technology to data science to fully embrace the opportunities to organize and apply their data in a systematic way to a range of drug development and patient care challenges.
The opportunities to analyze and use data continues to grow. Given the accelerating rate of learning about human biology and disease processes, the life science industry has begun to actively and use data science to achieve notable progress in drug conception, research and development.
The opportunity to take decisions based on data will help the industry to advance drug development, genomic research and clinical trials, and provide tools to answers the high-value questions in this increasingly competitive and evolving life science market environment.
BENEFITS OF INCORPORATING DATA SCIENCE INTO THE LIFE SCIENCE INDUSTRY
Incorporating data science and artificial intelligence in the life science industry will give valuable information on drug conception, drug development, risk assessment, and the effectiveness of the drug in clinical trials that will help you to improve the performance of R&D, and maintain the continuous improvement of your products and services. You are already seeing the use of data science in the current pandemic to predict virus spread and help in understanding the complex, data driven decisions to control the outbreak.
PROTECTION OF DATA AND RESULTS
You need to protect your valuable data and analysis from those who want to use your data. Data Protection is of paramount importance as the value of data increases. Training your staff is a key factor for the security of your data, as is working with a technical partner who understands the market and can withstand all the potential attacks.
CONCLUSION
Whatever the coming year holds, one thing is beyond doubt: Exciting new ways to create value are there for you, if you are willing to use the data, the tools and the techniques. Let PSC help you establish your secure data science program. Call us today.
Jul 28, 2020 | Consultant Tells All
OUTLOOK
The life sciences industry is evolving rapidly and so are the challenges associated with it. The business strategy ahead is to be proactive, time-bound results and the staff trained to be able to communicate and execute all documentation requests rapidly and flawlessly. The life sciences regulatory outlook for companies in these times should be to incorporate technology-driven, an experienced team to support global agency requirements including scientific, manufacturing, compliance, and legal.
UPDATED REGULATORS REQUIREMENTS FROM THE LIFE SCIENCE INDUSTRY
Regulators now require life sciences compliance programs to operate at a higher level. Due to the current pandemic, new pricing and privacy provisions continue to become law as drugs are taking center stage in the political debates around health reform. The stakes have gone higher and regulators have made it clear that “paper compliance” is not enough and that companies are expected to maintain a comprehensive, real-time view of their compliance programs’ effectiveness. The Life sciences companies have to be more aware and ready as they are responsible for helping to improve the lives of millions of individuals and maintain a high standard of public trust.
HOW DOES A REGULATORY CONSULTANT HELP
Regulatory consultants are responsible for pre-market and post-market activities for global life science submissions. Roles further include developing and implementing regulatory strategy, provide guidance on regulations and standards, review and maintain project documentation and records, participate in risk-benefit analysis for regulatory compliance, generate and manage submission files, and review and author submission documents. Regulatory Affairs Consultants have aids in the timely approval of multiple global submissions.
With so many complex issues in play, Regulatory Consultant will play a vital role in strategic conversations on product development and also try to make sense of a constantly changing life sciences regulatory environment.
VALUE ADDITION OF A REGULATORY CONSULTANT
A regulatory consultant will add value to your company by sharing valuable insights, helping you develop strategies that you can easily incorporate in your business model and match the requirements with current changing times. With compliance top of mind for all involved when a new product nears launch, a new system is brought online, or a new business relationship is explored, companies can be better equipped to do more than comply with life sciences regulations. Active compliance can also be a force to support the needs of your teams, and the process and technological tools we use, to be better integrated and aligned in your company’s mission.
Jul 23, 2020 | Consultant Tells All
Here’s Why You Need Seasoned Validation Experts for Your Business.
As one of the largest providers of Commissioning, Qualification and Validation services (CQV services) – PSC is a global behemoth in the life science industry. Our clients enjoy the benefit of our local and global reach. PSC offers a wide range of services, from facilities equipment to calibration matrices.
Because of the wide range of services that we provide, we can help our clients through every stage of a project.
Our experts focus on delivering practical and compliant results. That is why we have a proven success ratio on complex requirement projects for world-renowned clients.
But how can our services be of such importance to businesses?
Take User Requirements Specifications as an example.
User Requirements Specification (URS)
User Requirements Specifications describe what they REQUIRE from a software solution, new equipment, or new process. You want to write the specifications before the system is created or purchased.
The end-users or the owners of the system usually know what they want the system to do and the provide the input to write the URS. The URS is a critical part of software, equipment, or process development. If you’re unclear on what you’re trying to deliver – you’ll have a hard time knowing if you’ve successfully delivered it.
With the help of excellent user requirements, your business can achieve:
- A better end-to-end solution
- Satisfied customers
- Reduced cost
- Shorter duration
A good URS provides a firm foundation for a successful project.
You also need to evaluate the risks for any project and PSC has the risk assessement service capability for your system, project, or equipment.
Risk Assessment Services
Risk assessment is a vital component of any project. Risk assessment gives your business a solid analysis of the risks associated with your system, project, or equipment so you can achieve the results you want minimizing the cost while maintaining safety, reliability, and compliance. PSC understands the ins and outs of risk and risk assessment.
Our risk assessment professionals can be trusted advisors for your business while working alongside your business’s internal team.
Why Do I Need a Risk Assessment?
Think no further than Three Mile Island, Fukushima Dai-Ichi, etc. Did they need a risk assessment? Risk assessment is your primary tool to undertand and quantify risk, a necessity for every business in any industry. Through a risk assessment, you can understand the risks your business is exposed to. Risk assessment helps you to identify and implement cost effective measures to control or eliminate risks and adopt procedures that help minimize uncertainty and protect your bottom line.
Conclusion
Our seasoned professional are leaders of the life science industry PSC can provide end-to-end solutions from User Requirements Specification, Risk Assesssments and the associated implementation services to our customers.
Hire PSC professionals and you’ll be able to design, commission and build systems and facilities a lot quicker with less angst. Your products will reach the market faster, and you’re going to have a better return on your investment.
To know more about our PSC’s CQV services, contact us today or click here to know more.
Jul 14, 2020 | Be Meticulous
We Have Technical Writers Trained in Good Documentation Practices
There’s an industry event happening and you have been invited to present a whitepaper. Now, you need someone who can write the whitepaper for you. You need someone with the appropriate technological literacy.
Someone who can understand and elaborate on, for example, why your latest innovation changes lives and craft a compelling, persuasive paper that will grip your readers.
When you hire PSC – that’s the kind of balance we provide on a daily basis. Our highly educated and experienced team members have technical writing experience on various topics.
Wide Array of Experiences
From Global Harmonization to Regulatory Affairs – our writers have written on anything you can imagine. This means – whenever you hire us, our writers will ask questions from your designated subject matter experts (SMEs).
Gauging the right information enables our team to produce the excellent quality that you need. When our team has gathered all the data, we’ll be able to create all kinds of content. Our team consists of experts in:
And reviewing technical documents such as:
- Protocols
- Summary Reports
- Specifications
- SOPs (Standard Operating Procedures)
- Manuals
Here’s How You Can Go Wrong With Technical Writing
Many mid-sized engineering, startups, high-technology, and manufacturing companies don’t have a technical writer in their staff. So, whenever there is a need to write a technical document, who do you assign to write the document?
Do you assign the duty of documentation to the project’s engineer, marketing communications team member or a technician in the company? Business owners sometimes forget that writing is a skill in itself. Knowing a great deal about something doesn’t ensure that you’ll write well about it, too.
Even when businesses decide to hire a technical writer, they can make another crucial mistake. Since “price” is often the only priority, managers hire the cheapest resource which often leads them to hires the wrong resource. No one ever considers hiring a technical writing professional to write it right. Businesses often end up with a writer who isn’t experienced or has the wrong skill set. Here’s why:
- Everyone in your company has tasks of their own.
- You can’t expect professional work from a non-professional.
- Getting quality work at bargain prices is hard, and sometimes impossible.
Why You Need A Professional Technical Writer
A professional technical writer is well worth the money you spend. This can especially be true if you’re hiring a technical writer for a specific task.
Here are three reasons you should always hire a professional technical writing service:
- A professional technical writer devotes all of their time to your project. You can’t expect the same when you designate a writing task to an internal employee since they’re going to have work of their own, too.
- A technical writer is an expert on evaluating the content strategy, timeline and plan. That is why they are able to deliver on time
- Technical writers are aware of all the tools they can use to create content for you. Because of the tools they have access to, they are able to create content that is unmatchable and unique.
To hire us for your technical writing service needs, contact us today or click here to know more.
