Whitepapers

Engineering Resources

Written by our own Subject Matter Experts, Genesis' whitepapers are for individual and general audience consumption. Due to staff affiliations and professorships, we ask you to request permission to reproduce them for distribution.

The Design and Application of Pass-Thru Boxes in Life Sciences Cleanrooms

While airlocks have received quite a bit of attention from regulators and guidance authors, the smallest airlocks and their unique characteristics are poorly understood and rarely addressed. Pass-thru (or pass-through) boxes may well be viewed as small material airlocks, but in so doing we should not neglect the features which can make them perform differently (e.g. better) than airlocks. Pass-thru boxes differ from their “big brother” the material airlock in that they are never occupied by personnel, can be internally smooth and easily cleanable, are small and therefore present relatively less risk to the surrounding cleanroom. Add to this the myriad features, including ventilation, that can be added to pass-thru(s) and it appears the time for a thoughtful discussion of pass-thru(s) is well overdue. Download PDF

Norman A. Goldschmidt

SR. PRINCIPAL, VP ENGINEERING

Simplified Hydraulic Calculations

FOR RING DISTRIBUTION SYSTEMS

This whitepaper outlines some important design considerations for Clean-in-Place (CIP) systems, which are ubiquitous in the pharmaceutical industry. The goal for every CIP system is to remove residues from product contact surfaces. The residues must be reduced to pre-established criteria. Typically, critical process parameters for cleaning include the chemistry of the cleaning and rinsing agents, temperature, and flow rate. Certain design practices ensure that the critical parameters are met, help achieve the cleaning goal, and preserve the cleanliness of the process system, especially if it is not immediately returned to service. Download PDF

Stephen Hall, PE

SR. PROCESS ENGINEER

Design for Cleaning

FOR PHARMACEUTICAL MANUFACTURING SYSTEMS

This whitepaper outlines some important design considerations for Clean-in-Place (CIP) systems, which are ubiquitous in the pharmaceutical industry. The goal for every CIP system is to remove residues from product contact surfaces. The residues must be reduced to pre-established criteria. Typically, critical process parameters for cleaning include the chemistry of the cleaning and rinsing agents, temperature, and flow rate. Certain design practices ensure that the critical parameters are met, help achieve the cleaning goal, and preserve the cleanliness of the process system, especially if it is not immediately returned to service. Download PDF

Stephen Hall, PE

SR. PROCESS ENGINEER

Energy Efficiency Makeover Yields
Utility Incentive Rewards.

GSK’s energy efficiency retrofits and enhancements return $2 million to the company’s coffers. GSK’s energy efficiency retrofits and enhancements return $2 million to the company’s coffers. Changes in global climate are major concerns among scientists and the public alike. Download PDF

Russell R. Watters, CMVP

SR. ENERGY ENGINEER

Space Classification for Sterile and Biopharmaceutical Facilities

Over the last several years we have observed a general misunderstanding of the correlation between FDA environmental requirements and those of the EU, WHO and PIC/S. The purpose of this paper is to clarify the understanding of the correlation and differences between the classifications recommended by these bodies. Download PDF

Norman A. Goldschmidt

PRINCIPAL, ENGINEERING

BMS Validation Strategy

Whenever room environmental parameters are critical to product quality Building Management System (BMS) designers face a choice regarding the control and recording of this GMP critical information... What to validate, and how? Download PDF

Norman A. Goldschmidt

PRINCIPAL, ENGINEERING

HVAC Pre-filtration In Pharmaceutical Facilities

A common challenge in the design of sterile filling and biotech facilities is selection of the appropriate type of pre-filtration to employ ahead of supply HEPA or ULPA filters serving processing areas. This document suggest an approach intended to assure compliance with applicable regulation and industry guidance - specifically, FDA 2004 “Guidance for Industry, Sterile Drug Products, Produced by Aseptic Processing, Current Good Manufacturing Practice”, EudraLex Vol.4 Annex 1, PIC/S and WHO TRS 957 Annex 4. Download PDF

Norman A. Goldschmidt

PRINCIPAL, ENGINEERING

First Steps for Sustainable Bio/Pharma HVAC

The bad news is that energy efficiency has understandably never been job one in the pharmaceutical industry. The good news is that opportunities abound for real progress as a new emphasis on sustainability grows. The author offers more than a daily dose of industry-specific insight while outlining why higher efficiency need not be a bitter pill to swallow.
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Norman A. Goldschmidt

PRINCIPAL, ENGINEERING

Cross-Contamination – Protection in HVAC

In order to comply with widely established GMP regulations requiring "minimizing the risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air…" An evaluation of potential for cross-contamination via HVAC should be part of the risk assessment in multi-product facilities.
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Norman A. Goldschmidt

PRINCIPAL, ENGINEERING

Energy & Sustainable Design – Building Green

Is a Sustainable cGMP Manufacturing Facility Achievable? In 1999, 16% of the world's population consumed 80% of its natural resources. The United States, with 4% of the world's population, consumed 25% of the world's natural resources.
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Bernard C. Friel, PE

ENGINEERING, PRESIDENT & PRINCIPAL

Major Cost Savings from Process Chillers and Refrigeration Systems

GSK US Biopharms, Global Manufacturing & Supply, Primary Supply & Antibiotics. Most pharmaceutical sites have a requirement for process chillers or for process refrigeration systems.
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Contributor: Derek Demchak

PROJECT ENGINEER, MECHANICAL