The Microrite team are professional, passionate, and have a high level of expertise in the areas they offer consultancy. Microrite works as a team with clients, understands clients priority and at the same delivers quality work. We are setting up new facility and working with them has been a very good learning experience as we have identified and improved systems which in turn reduce patient risk.
– Associate Vice President, CQA-Aseptic Operations
Alembic Pharmaceuticals Ltd.
I have attended courses and utilized Microrite’s expertise in multiple companies and in a number of ways over the last 18 years. I have seen true value added to every project and every business that Microrite has serviced. Microrite consultant’s approach and solid experience has helped in resolving some complex contamination issues, while increasing the skills and knowledge of all involved. They have a trained a large number of my employees on foundational principles of contamination control which I am certain helped them become more valuable employees to any company they worked for. Microrite has also been a key voice and team member in assisting with proactively designing several facilities that I have been involved with, and helped assure that compliance and contamination control was built in up front.
I can truly say that the organizations I have been a part of became better after utilizing Microrite.
– VP Product Supply
ALK Source Materials
The Microrite team has closely worked with us (Emcure) for our Laboratory & Manufacturing area aseptic practices improvement plans as well as on certain technical matters. We have found that the Microrite team works with a whole hearted commitment, dedication and an all-round inclusive approach. They are experts in providing practical solutions while ensuring compliance to complex regulatory expectations. They have vast experience in microbiology laboratory work practices, aseptic practices in manufacturing areas as well as regulatory requirements. They have been instrumental in helping us proactively improving our practices, resolving complex technical challenges and simplifying & rationalizing many a sterile product manufacturing facility & laboratory management requirements.
– Sr. Director QA & QC (Injectables)
I have worked with Microrite on several projects over the past few years. I find the Microrite team to be professional, extremely knowledgeable and current with industry requirements and best practices.
Microrite has provided us with consulting and training services related to contamination prevention, contamination monitoring, contamination investigations, and contamination control. The trainings are well put together and contain a healthy dose of real life examples that make the content easy to understand and absorb. They have also supported equipment qualifications through airflow visualization studies to ensure aseptic processing conditions are maintained in our laminar flow cabinets. Most recently, Microrite was tasked to set up risk based environmental monitoring program in our GMP suite in compliance with current standards and guidance, help plan disinfectant qualification studies and provide guidance in microbial contamination related investigation. There was good collaboration between Microrite and my team in both planning and execution leading to timely and satisfactory completion of all the deliverables. Microrite is the go to team when it comes to cleanrooms and contamination control.
– Sr. Director, MSAT
I have worked with Microrite for several years on both planned projects and unplanned events. Ziva and her team take a pragmatic approach to ensuring the highest level of product quality and cGMP compliance. The Microrite team has helped my solid oral dose facility identify where new controls were beneficial or old controls were overzealous; and Ziva was the first person that I called when a new technology created new microbial/particulate challenges.
– Associate Director, Pharmaceutical Development Operations and Supplies
Global Pharmaceutical Corp.-HQ in California
Microrite successfully executed Smoke Studies using their equipment and accessories, recorded via digital video, edited and provided final report. Microrite’s strengths are having a diverse expertise, an extensive knowledge and experience in each area of expertise and rapid responses to urgent requests.
– QC Director, Microbiology and Sterility Assurance
Global Pharmaceutical Corp.-HQ in California
Through our Cleanroom Supplies Sales Representative, I heard about Microrite Inc. and their services. My first contact request was to ask for some support with an airflow study. Their consultant could provide us very helpful hands-on information which we could transfer into sustaining process improvements. The first satisfying results strengthened our confidence working together with Microrite Inc. and we reached out to them two times more. Once for an HVAC question where we needed some expertise on and the other time we had some questions related to Static Charge in the manufacturing process. Also here we were not disappointed and could again transfer the findings into new concepts. The great advantage of working together with Microrite Inc. is the level of expertise based on many years of experience in the field. It is very straight forward to work with them and setting clear objectives prior to getting started. Even for me with 20+ years of experience in Contamination Control I can definitely say that I could learn quite a bit from their team and how they approach a project with a strong problem solving mindset. As working for customers in critical process environments is their daily business confidentially was never an issue.
– Contamination Control Coordinator
Sanaria has benefited immensely from the smoke studies conducted by Mr. Morgan Polen from Microrite. The exercise of smoke studies with the proprietary equipment and solution used by Microrite helped to visualize the air flows in the clean rooms in an unambiguous fashion; the testing also helped in clearly identifying flaws in the unidirectional air flows. The proprietary solution could be cleaned up easily and no contamination of the clean rooms was observed after. Working with Morgan was like working with our own team member and we all learned a lot from him.
– Senior Director, Quality
The Microrite team has met our needs and exceeded our expectations. They developed contamination control strategies specific to our process and product which in turn has allowed us to identify and resolve challenges proactively. The team is very knowledgeable and work cohesively to provide practical solutions. Their focused methodology to working hand in hand with the client has resulted in compliance as well as time and cost savings. The Microrite team has done an outstanding job and it has been wonderful working with them. We continue to work with them on new phases of our project.
– Associate Director, Quality Assurances
Agenus West, LLC
The Microrite team met and exceeded our needs and expectations. Their very knowledgeable representatives assessed our facility, helped develop procedures, provided clear actionable advice, and conducted training. They identified potential problems before they occurred saving us both time and money. The Microrite team did an exceptional job for us and it was a pleasure working with them.
– Executive Director
Spring Point Project
Our startup used Microrite’s consulting services to help with quality related improvements. Our Microrite consultant was very knowledgeable, methodical and conscious of our budget. At our regulatory audit, the inspectors were very impressed by how our quality issues were addressed and handled by Microrite. As Vice President of Technology and Operations, I whole heartedly recommend Microrite’s services to anyone needing quality, validations and microbiology services.
– Vice President of Technology and Operations
OSNovation Systems, Inc.
The most valuable aspect of Microrite’s services is that they believe in teaching clients the how and why. They didn’t simply hand over document templates to be released in our own quality system; they encouraged revisions and offered their own knowledge and experience so that we could learn about the process.
– Quality Assurance
Microrite consultants are Top-Tier. Their knowledge base of Microbiology and Quality are outstanding. They are focused on providing exceptional consultation services and training. Associates at Microrite stay current on the changing world of FDA/EU Regulations in order to provide the most up-to-date assessment of your internal systems.
– Sr. Supervisor Warehousing and Logistics
Abbott – (formerly Thoratec, Inc.).
I brought in Microrite, Inc. when I was with J&J where I oversaw the tech transfer/scale up activities of a macromolecule aseptic pilot plant. The plant was one of a kind and built to bring implantable drug delivery technology to market, it utilized a sophisticated isolation technology process that the consultant from Microrite orchestrated much of. Specifically they helped in the areas of Quality Systems, Microbiology, and Media Fills. They are extremely experienced and knowledgeable in areas of Quality Assurance and Microbiology but more impressive is their ability to lead numerous cross functional groups effectively.
– Marketing Operations and Portfolio Business Manager
I’ve had the pleasure of working with Ziva and Microrite for many years and several courses. I’ve attended Intensive Training in Contamination Monitoring and Control, Fungal Identifications and Microbial Contamination Investigations, to name a few. Ziva’s training differs from other training I’ve attended. Ziva doesn’t generalize or stand there and recite the regs. She uses real life examples, based on real life experience and regulatory guidance. She helps relate her topics to what we’re doing, what’s current in the industry and what’s changing. She’s passionate, animated and engaging in her delivery. Her training material is current and relevant to our industry and quickly becomes a reference manual.
– Sr. Manager, Microbiology