cGMP QUALITY
cGMP QUALITY
Product safety and quality is naturally of prime importance to pharmaceutical and biotech manufacturers, and supporting our clients to achieve and maintain adherence to Current Good Manufacturing Practices (cGMP) and other internal and external regulatory requirements is a core competency of EECO2.
The design, installation, operation and maintenance of heating, ventilation and air-conditioning (HVAC) and cleanroom systems play an important role in ensuring that appropriate quality standards are achieved.
HVAC system design often influences facility layouts with regard to items such as airlock positions, doorways and lobbies, which in turn have an effect on room pressure differential cascades and cross-contamination control.
Appropriate temperature, relative humidity and ventilation should of course be maintained during the manufacture and storage of pharmaceutical products in order to ensure product quality and to help allow the accurate functioning of other equipment.
EECO2 can provide guidance through the regulatory and compliance landscape and ensure that your facilities are operating at maximum efficiency, without compromising safety or quality.
LATEST cGMP QUALITY NEWS
An efficient, safe route to EED Article 8 compliance for all your European sites
The 2012 Energy Efficiency Directive establishes a set of binding measures to help the EU reach its 20% energy efficiency target by 2020.Under Article 8 of this directive, each EU Member State must meet certain energy savings targets between 1 January 2014 and 31 December 2020.In the UK, the Energy Savings Opportunity Scheme (ESOS) has…
Cleanroom Management Summit
EECO2’s Head of Life Sciences Keith Beattie will be speaking at the inaugural Cleanroom Management Summit, to be held in London on 15th and 16th November this year.The two day event will bring together key industry personnel from the cleanrooms, pharmaceutical manufacturing and microbiological industries. The conference will discuss regulations and compliance, information in validation…
cGMP QUALITY CASE STUDIES
HVAC energy savings delivered by optimisation of a dehumidification system
project brief
Our brief was to reduce HVAC energy consumption without adverse impact on product quality or safety.
OUR RESULTS
Energy savings delivered (per year)
1,165,336 kWh
Energy cost savings identified (per year)
£57,000
Emissions reduction (per year)
233 tonnes
of CO2
Tablet manufacturing suite heating, ventilation and air conditioning system upgrade
project brief
EECO2 was asked to assist in reducing energy demand at a tablet manufacturing facility without compromising product quality or regulatory compliance.
OUR RESULTS
Energy savings (per year)
363,000 kWh
Energy cost savings (per year)
£36,000
Emissions reduction (per year)
336 tonnes
of CO2
Blow fill seal (BFS) filling room air change rate reduction
project brief
Existing HVAC system designed to provide Grade A room conditions at high energy cost. Process changes resulted in requiring a Grade C room as background for a BFS filling line.
OUR RESULTS
Energy savings identified (per year)
455,000 kWh
Energy cost savings identified (per year)
$63,000 USD
Emissions reduction (per year)
387 tonnes
of CO2
Identifying HVAC energy reduction strategies at a pharmaceutical manufacturing facility
project brief
To identify HVAC energy reduction strategies throughout various key manufacturing and storage spaces at a single key manufacturing site and quantify potential cost savings.
OUR RESULTS
Energy savings identified (per year)
6,788,000 kWh
(11% site energy reduction)
Energy cost savings identified (per year)
$350,000 USD
Emissions reduction (per year)
2,311 tonnes
of CO2 emissions
Identifying HVAC energy reduction strategies for an oral solid dose pharmaceutical manufacturing facility
project brief
To identify HVAC energy reduction strategies throughout various manufacturing spaces and laboratories at a single key manufacturing site and quantify potential cost savings.
OUR RESULTS
Energy savings identified (per year):
4,564,000 kWh
(4,564 MWh)
Energy cost savings identified (per year):
$377,000 USD
Emissions reduction (per year):
2,065 tonnes
of CO2 emissions
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