This section of the Vipsit site focuses on our hard skill sets. This page is intended to give an overview, enjoy the sub-folders for more insight.
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PAST PROJECTS – KEYWORDS
Animal facilities, Accident/incident/near-misses/close-catches systems, BOD, Biological agents, BRM implementation, Biorisk manuals, Biosafety, Chemistry, CIP, Cleaning validation, Commissioning, Communication plans, CONOPS, Contract Specifications Review & Analysis, CWA 15793 & CWA 16393, Data Analytics, Decontamination, 30%-60%-90% Design reviews, Diagnostic laboratories, DQ, Equipment, Eradicated diseases, Facility assessments, Facility design, Fermentors, GMO’s, GMP production, HEPA filters, High containment, HVAC systems, Impact assessments, Instructional Design, ISO standards, IQ, Kast Hydrology, Kill systems, Laboratories, Large scale productions, Media systems, Metrics, Mixed methods Study Development & Analysis, O&M plans, Operational readiness, OQ, Performance indicators, Pharmaceutical plants, Pilot plants, PQ, Project Management, Qualification, Qualitative Data Analysis, Quantitative Data Analysis, Regulatory compliance, Research laboratories, Reviews, Risk assessments, Room decontamination, Single Use Systems and Equipment, SIP, SOP’s, Start-up Testing, Sustainability, Systems Operational Testing, TABLEAUX, Training, User requirement specifications (URS), Utility systems, Vaccines, Validation, Waste
FACT FINDER
Bio / Chem / Animal facilities
How should your new laboratory look ? What do you want… and what do you actually need?
We have experience in arranging fact finding exercises for Basis of Design [BOD], stakeholder identification, user interviews, Design Charrettes and prioritization of needs, wants and aspirations. Are your GMP production staff, your research scientists, technicians, maintenance engineers and waste handlers in agreement? Or far from? Do you need a facilitator to run the initial meetings and manage expectations?
How do you decide on what international best practices to follow?
What national guidelines and regulations apply? None existent? What international best practices should you chose that are applicable to your situation?
It starts with due diligence.
Successful facility design and layout does not come by itself. GMP clean-room productions and bio/chem containment facility projects need dedicated biological and chemical risk management focus with regard to hazard identification, product purity, single point of failure, and 24/7/365 operation requirements. That focus need to be there from the very first hour. In addition these facilities needs a well defined program (small/medium/large scale productions) and somebody who can communicate this clearly to the design architects and engineers … that preferably are experienced in exactly this field.
Do you have this risk management driven lab design expertise in-house?
If the analytical risk management part of the project is too big for the in-house team or you are looking for an independent review and sanity check – we can support.
Have you written an URS before?
Development of user requirement specifications (URS) and functional design specifications (FDS) are long and complex documents. They ensure that you get what you want from a GMP product purity, experimental and QC test animals, and staff safety perspective – if you know how to write them correctly. Have you done it before? Or is this the first time? Do you know how to write measurable and well defined requirements, that can be directly compared during the bidding process and later verified and tested during the GMP DQ, IQ, OQ and PQ phase? Would you like a little help to get started on the right foot?
FORTUNE TELLER AND ORACLE
What If …. it suddenly went wrong?”
Robust risk and vulnerability assessments serves as your crystal ball and are the keystones in safe bio/chem risk management of large scale GMP biologicals and pharmaceutical facilities handling biologicals and chemicals. Robust multi dimensional risk assessments are the spine and axle on which all other decisions rely. HAZOP, HACCEP, What-if, Fishbone, Control band, BowTie, LOPA Qualitative, Quantitative, …. The tools are many for the large scale industry and are much more complicated than the easy one dimensional risk assessment process for a diagnostic or research lab, even if these might be handling high consequence pathogens.
Do you have a structured approach?
Do you know how to save time and work using “blocks” in your risk assessments?
Can you communicate and defend your risk mitigation strategy in a single page and in 3 minutes?
Have you thought of formulating and handling the data vase “blocks” in such a way that they can auto-feed into reports? Can you visualize your risk picture?
Rear view mirrors and past incidents
Sometimes you do not need a crystal ball, just a rear mirror. Do you collect “good catches” and do you have accident and incident reports with associated root cause analysis that can inform improved future procedures and design? Do you need help to build this very important system?
DREAM-CATCHER
What are your dreams and long term goals?
Without a clearly formulated VISION and MISSION, it will be a waste of time to try to define the STRATEGY of a company or a personal career. Do you have experience in facilitation of such a dream-catching process? Would you like ideas or support to the initial steps?
A THIRD EYE
Was anything forgotten?
Are you confident that the lab planners, design architects and engineers included all the right technical solutions that can meet the requirements from your GMP and other guidelines and regulatory documents? Have they done it before? Successfully? Do you need an extra set of eyes on the preliminary design documents, and drawings? Design reviews of 30%, 60%, 90% project drawings and descriptions are often well spent effort.
We review and sanity check risk assessments, the complex GMp/containment design rationales, protocols, SOP’s, guidelines, scientific papers, and reports. We will be the devils advocate and let you know where you lose your audience whether it is your inspector, your scientific audience or your staff. Sometimes the complex scientific message needs to be explained so your grandma would understand it to have an optimal impact. … KISS. Note, we did not offer to write these documents for you, we are willing to review and help you identify the guidelines that might be applicable.
GUIDELINE GEEK
Are you comfortable when it comes to “divide and conquer”?
It is a rare project if regulatory compliance is straight forward. We help with prioritizing the contradicting requirements from different regulating bodies by developing comparative risk assessments that highlight the clashes and illustrate the best compliance path forward towards final authorization and approval of the facility.
The rationale behind the madness
Have you ever before developed a documented design rationale of why some of the containment requirements have been met in a non-traditional way, due to another GMP guideline’s demands? Are you prepared and ready? Is the facility documentation ready for the upcoming GMP inspections? The importance of documenting these design rationales cannot be stressed enough. They are the last line of defense for ensuring that the facility will continue to serve as intended. When you have retired, others will need to defend the original design philosophy during upgrades and modifications. No-one can recall why, whom, how, where or when it was decided to chose an unusual technical solution and what the original reason was. Unless you leave a clue for the coming generations.
Are new and daunting guidelines hitting your field?
Do you know how to start and when to finish the preparation for the inspectors? Do you feel you know when enough is enough and how to prioritize the implementation path, identifying low and high hanging fruits end executing in a structured manner? Can you identify the critical path through the project?