Critical Environments Columns
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Another "Partnership" Sob Story: A Dear John Letter To Biotech Landlords
2/26/2020
The “courtship” of a biotech tenant and a landlord often takes months, with negotiations over lease length and costs. Initially, the “romance” expects that the two parties will exist together for the long term; however, that is rare. Here's how to break off negotiations on the proposed lease and pursue other properties.
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Cats In The Warehouse! 9 Real-Life Blunders To Avoid In Your Pharma Facility
12/13/2019
Our previous review of humorous and horrifying pharmaceutical facilities blunders Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them) revealed our industry is flawed like any other. Here are some examples from the engineering side of the business.
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Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them)
11/13/2019
There are situations we have come across where we really scratch our heads and say, “What did they just do, and what were they thinking?” This article describes a series of events and activities that we have seen that are at once amusing, baffling, and revealing of the flaws in our industry.
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ISO 22519: An Unnecessary, Faulty, And Confusing Standard
10/11/2019
The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.
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A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility
10/9/2019
The road to successfully acquiring a property for a biotech startup is littered with potholes and barriers. This article provides a technical due diligence checklist that the operating organization can use to frame its decision-making process.
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Danger Ahead: What Biotech Companies Need To Know About Leasing Space
9/25/2019
One of the most significant moves for a growing biotech or pharmaceutical company — sometimes considered as a graduation step — is the acquisition of property to conduct clinical trials and manufacture commercial products. In the first installment of this two-part series, we will explore what considerations companies need to make before they decide what type of property to pursue.
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Project Execution Models For Biopharmaceutical Facilities
8/29/2019
Project execution and project management are probably two of the topics that are most written about but least understood by the biopharmaceutical industry. This article is not about the theory of management, but it is a primer on approaches to project execution, some of which may assist the reader in understanding their path of least risk.
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Environmental Isolates: What’s The Proper Use Of In-House Cultures?
6/24/2019
Use of environmental isolates in the pharmaceutical microbiology laboratory has been increasing in popularity. This article discusses the current regulations andguidance documents, regulatory expectations, and expert opinions on the use of environmental isolates.
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Off-Site Modular Fabrication Of Biopharma Facilities — What You Need To Know
6/17/2019
Measurable benefits of off-site module construction are becoming more evident, and it is emerging as a viable method for delivering a greater degree of predictability. Furthermore, market constraints driven by shortages of craft labor, lagging productivity, project complexity, and competitive forces are contributing to biopharma’s move toward modularization.
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Incorporating Natural Hazards & Distributed Infrastructure Into Risk Management For Biopharma Operations
4/25/2019
Natural hazard events may seem like distant topics to some in the biopharmaceutical industry, but they hold relevance for all companies. Opportunities exist for risk management, including an important lesson in avoiding the gradual acceptance of such events as normal, until an even greater catastrophic event occurs.