Angstrom Technology Completes Azzur Cleanrooms on Demandâ„¢ Raleigh facility

Angstrom Technology Completes Azzur Cleanrooms on Demandâ„¢ Raleigh facility

by | Jul 7, 2023 | Pharmaceutical Cleanrooms

Azzur Group appointed Angstrom Technology to build its latest Cleanrooms on Demandâ„¢ (COD) Raleigh facility in Morrisville, NC. Azzur Cleanrooms on Demandâ„¢ offers a hybrid early-phase manufacturing model. Early-phase manufacturers face specific challenges when starting up and scaling out. COD can remove barriers, such as the need for clinical manufacturing capability and lengthy facility design-build timeframes. Morrisville is minutes from the celebrated Research Triangle area of North Carolina, making it a prime location for this new state-of-the-art facility.

The 24,000 square foot Cleanrooms on Demand™ Raleigh facility features 24 independent cleanroom suites each with a Material Airlock (MAL), Personnel Airlock (PAL), Cleanroom and Exit PAL.  Shared entry and exit corridors provide easy access to and from each cleanroom via the locker room and changing area near one end of the cleanroom.  On the opposite end of the cleanroom, material airlocks provide a path for large equipment to enter the suites via the GMP warehouse.  All cleanroom suites are controlled and monitored by advanced systems which are tied into the building management system.

Azzur Morrisville cleanroom render

Cleanrooms on Demandâ„¢ locations

Azzur Cleanrooms on Demandâ„¢ Raleigh is the first COD facility Angstrom has completed for the Azzur Group and the 4th in the Azzur COD group. In June, Angstrom attended its grand opening ceremony.

Azzur Group plans to open additional Cleanrooms on Demand facilities in locations across the U.S. over the next two years. Our global structure allows us to project manage builds in multiple locations. Consequently, Angstrom Technology is also under construction on Azzur COD facilities in Devens, MA, and Alameda, California.

At Angstrom Technology, we have the capability to deliver exceptional cleanroom installations. Working with us across multiple facilities provides consistency in cleanroom design, specification, monitoring, and validation. This approach generates efficiencies and drives value. Equally important, it instills confidence in the performance and reliability of your controlled environments.

SPEAK WITH THE EXPERTS AT ANGSTROM TECHNOLOGY

Angstrom Technology partners with the world’s leading contamination control brands so we can design, build, and install high-spec, turnkey cleanrooms to meet your critical requirements across the US and around the globe. Using proven design strategies and quality build systems, you can trust that your work and employees will always be protected.

Request a cleanroom quote today, or contact our team for more information.

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Global Cleanroom Expertise: Installation

Global Cleanroom Expertise: Installation

by | Jun 23, 2023 | Cleanroom Installation

Angstrom Technology understands the importance of effective cleanroom installations that alleviate potential issues and reduce timescales for our global clients.

With our extensive experience and expertise, we can proudly say that we install cleanrooms across the globe. As cleanroom experts, we have high expectations for build quality and can deliver a consistent standard across multiple sites worldwide. We aim to provide our customers with reliable and efficient installations that meet their needs.

At Angstrom Technology, we take cleanliness seriously during the build process. We operate in a manner that minimizes dust and waste, ensuring minimal disruption for our clients. We understand that a clean environment is crucial for various industries, and we prioritize maintaining the highest cleanliness standards throughout the installation process.

Cleanroom build partners

Our experienced site superintendents and installation technicians deliver clean and precise installations for our cleanroom projects worldwide. We approach each project focusing on our customers’ needs, tailoring our installation methods accordingly.

To provide cost-competitive and qualified installation services worldwide, we have established strategic partnerships with local labor forces across the globe. This approach allows us to leverage local expertise while ensuring that our knowledgeable site superintendents and staff provide supervision and maintain our high standards.

Our robust approach to project management and installation caters to our customer’s needs:

  • Project Management: We provide comprehensive project management services, taking responsibility for installation, trade work coordination, and subcontractor management. With our expertise, we ensure a seamless and efficient installation process.
  • Full Turnkey Solution: Our experienced site team handles all aspects of the build, ensuring minimal disruption to your team. We take care of every detail and hand over the keys when the installation is complete.

At Angstrom Technology, we have the capability to deliver exceptional cleanroom installations globally. With our installation flexibility, focus on cleanliness, and dedication to customer satisfaction. We are your trusted partner for cleanroom projects around the world.

SPEAK WITH THE EXPERTS AT ANGSTROM TECHNOLOGY

If your facility needs a new cleanroom, Angstrom Technology can design, build, and install one that meets your specifications. Using proven design strategies and quality build systems, you can trust that your work and employees will always be protected.

Request a cleanroom quote today, or contact our team for more information.

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Global Cleanroom Expertise: Effective Project Management

Global Cleanroom Expertise: Effective Project Management

by | Jun 6, 2023 | Cleanroom Installation

Today, we’re delving into the world of project management. Specifically, good project management! Its impact on the outcome of cleanroom projects cannot be overstated. So, let’s explore why good project management is so important!

Smooth Sailing for Project Delivery

Imagine a cleanroom installation where everything runs like a well-oiled machine. Deadlines are met, communication is seamless, and everyone’s happy. That’s the power of good project management! Angstrom Technology appoint a dedicated project manager for each cleanroom build. It’s their job to make sure that the delivery of your project is as smooth as possible. From start to finish, your project manager will be your go-to person, ensuring that the entire build comes together perfectly.

Your Personal Project Concierge

Ever had a question or a concern about a project but didn’t know who to turn to? Not with Angstrom Technology! Your project manager is like your personal concierge. They will be there to answer any queries you may have. Whether it’s about timelines, resources, or any other aspect of the project, just reach out, and your project manager will provide you with the support and information you need.

Prompt and Professional Communication

Communication is key, and we take it seriously. Angstrom Technology understand how important it is to always keep you in the loop. That’s why we will be responsive and maintain a professional manner in all our interactions. With every update, your project manager will ensure that you’re well-informed about the progress and any potential challenges that may arise. You can trust that we pay attention to every detail and keep you confident in our project’s success.

Overcoming Challenges with a Positive Attitude

In every cleanroom build project, obstacles are bound to come up. But here’s the thing, we see them as opportunities, not stumbling blocks. Challenges are meant to be conquered, and we’re here to tackle them head-on. By identifying and addressing potential issues in real time, your project manager will navigate through the hurdles to keep our project on track. So, no need to worry when unexpected roadblocks arise—we’ve got the solutions!

Information Platform for Transparency

Transparency is crucial in project management, and we’ve got you covered. Your project manager will provide you with an information platform that keeps you in the loop every step of the way. Monthly programs, two-week lookaheads, and weekly progress reports are just some of the tools I’ll use to ensure clear visibility of the project’s status. You’ll always know where we stand, and together, we’ll make informed decisions to achieve our goals.

Beyond Project Completion

Our commitment to you doesn’t end when the cleanroom project is delivered. We’re here for the long haul, ready to address any concerns, queries, or additional requirements you may have even after the handover. You can count on us to remain accessible and responsive, whether it’s through email or phone. Your satisfaction is our priority, and we’re here to support you even beyond the project’s completion.

So, that’s the power of good project management! From providing a seamless service to being your personal support system, a professional project manager from Angstrom Technology will ensure your project’s success. With open communication, a positive mindset, and a commitment to your satisfaction, we’re ready to turn any cleanroom project into a triumph. Let’s embark on this journey together, and together, we’ll achieve greatness!

Remember, we’re just a call or an email away, so don’t hesitate to reach out. Here’s to a successful cleanroom build!

 

SPEAK WITH THE EXPERTS AT ANGSTROM TECHNOLOGY

If your facility needs a new cleanroom, Angstrom Technology can design, build, and install one that meets your specifications. Using proven design strategies and quality build systems, you can trust that your work and employees will always be protected.

Request a cleanroom quote today, or contact our team for more information.

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Global Cleanroom Expertise: Capabilities

Global Cleanroom Expertise: Capabilities

by | May 19, 2023 | Cleanrooms

As you may already know, the Angstrom Technology Group of market leading cleanroom companies in the US, UK, and Europe has capabilities to provide multinational services to our global clients. But what does this mean for our customers?

The stringent control of process variables is a global requirement for pharmaceutical, electronics, and biotech industries worldwide. Our cleanrooms support top-tier multinational organizations to increase quality at sites across the world.

 

EXPANDED PRODUCT RANGE

Through in-house expertize and collaborations with specialist industry-partners, we can deliver facilities with precise requirements, such as battery dry rooms or cell and gene therapy suites.

 

CONSISTENT QUALITY

When it comes to global operations, maintaining consistent quality standards is crucial. Angstrom Technology understands this well and no matter where you are in the world, we can deliver compliance to the applicable regulations. This commitment to quality gives you the reassurance that partnering with Angstrom Technology will result in reliable and high-performing solutions for your business.

 

FASTER RESPONSE TIMES

In a fast-paced business environment, time is of the essence. Angstrom Technology’s global network of partners enable us to reduce shipping and installation times significantly. This streamlined approach translates into improved operational efficiency for your business, giving you a competitive edge.

 

LOCALIZED SUPPORT CAPABILITIES

By having a network of support teams strategically located across different regions, Angstrom Technology ensures that you receive personalized attention and timely assistance. This localized approach strengthens our commitment to customer satisfaction and builds long-lasting partnerships.

 

COMPETITIVE PRICING

Angstrom Technology’s global capabilities enable them to optimize their supply chain and take advantage of economies of scale. This optimized approach allows them to offer competitive pricing without compromising on quality. By partnering with Angstrom Technology, you can access cost-effective contamination control.

 

ACCESS TO GLOBAL EXPERTIZE

With a multi-disciplined, in-house team of cleanroom experts, we have expansive industry experience, with applied knowledge and skills across the globe, such as our global regulatory governance team.

 

GLOBAL CLEANROOM PROJECTS

 

Capabilities - Global cleanroom customers

 

SPEAK WITH THE EXPERTS AT ANGSTROM TECHNOLOGY

If your facility needs a new cleanroom, Angstrom Technology can design, build, and install one that meets your specifications. Using proven design strategies and quality build systems, you can trust that your work and employees will always be protected.

Request a cleanroom quote today, or contact our team for more information.

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Global Cleanroom Expertise: Regulatory Governance Team

Global Cleanroom Expertise: Regulatory Governance Team

by | May 5, 2023 | Cleanroom Standards, Pharmaceutical Cleanrooms

The regulatory landscape for cleanrooms can be complex. On top of managing the requirements of the ISO 14644 suite of standards, you may also need to comply with cGMP (Good Manufacturing Practice) guidelines and those of industry regulatory bodies. But the experts at Angstrom Technology are committed to supporting you through successful audits. All cleanroom projects with a requirement for cGMP compliance have oversight from our dedicated regulatory governance team. 

With over 40 year’s combined experience in cGMP and pharmaceutical industries, this level of in-house expertise sets us apart from other cleanroom companies. In this blog — the first in our Global Cleanroom Expertise series — we explain how we can support your regulatory compliance.  

 

Meet the Regulatory Governance Team

Global Compliance and Quality Assurance Manager

Global Compliance Lead

Joan Benson - Global Compliance and Quality Assurance ManagerSimon Rice - Global Compliance Lead
Joan has 30 years previous experience in Cell and Gene Therapy, Academia, Pharmaceutical Industry, Contract Clinical Research and Hospital Aseptic facilities. She was front facing regulatory inspections in MHRA, FDA, HTA and HFEA for 20 years.Simon has 8 years previous experience in the production of radiopharmaceuticals within a fully accredited GMP facility manufacturing sterile pharmaceuticals. This gives him a unique understanding on the implications of GMP.

 

Regulatory compliance services

Our cleanroom systems can be qualified to cGMP, and the required ISO classification. Not only that, but they can also meet any applicable international engineering and building standards and regulations. Our skilled and multi-faceted team can provide the following key services to support your compliance: 

  • Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) 
  • Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) 
  • Validation 
  • Audits of facilities and Quality Management Systems 
  • Gap analysis 
  • Mock regulatory inspections 
  • Bespoke validation studies 

 

Regulatory governance successes

Our team has led high-profile global cleanroom projects to regulatory compliance. There are just a few of their recent successes. 

  • Led cleanroom validation (DQ, IQ, OQ, PQ, FAT, SAT and a wrap-around validation package covering EMS, VHP systems and cryostorage) for a 33-room Cell and Gene Therapy Manufacturing Facility. 
  • Led cleanroom validation (DQ, IQ, OQ, PQ, and all commissioning data) for a 6,500 Cleanroom Facility in their 11,000 square feet Single-Use Bioprocessing Technologies Manufacturing Facility. 
  • Supported numerous clients on the delivery of their projects with regulatory support on all aspects including design, validation, and commissioning 
  • Led cGMP qualification packages for current clients with GMP facilities 
  • Gap analysis for leading clinical research units 

 

Ready to start your cGMP cleanroom project? Contact us

We are committed to supporting you through successful audits and inspections, now and in the years to come. To learn more about our cGMP cleanroom design-build services, request a quote or contact us. 

 

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