Showing posts with label Pharma Engineering. Show all posts
Showing posts with label Pharma Engineering. Show all posts

ISO 11011: Standardizing Energy Audits

ISO 11011:2013 aims to standardize the energy audit process by establishing guidelines for assessing compressed air leaks. It also addresses the competency of the assessor and the methodologies employed.
 For more than a decade, money wasted through compressed air leaks has often been cited as the number one quick fix manufacturers can take to begin getting a hold on their energy costs. Going back to 1998, a Department of Energy “Compressed Air Challenge” fact sheet notes that “leaks can be a significant source of wasted energy in an industrial compressed air system, sometimes wasting 20-30 percent of a compressor’s output. A typical plant that has not been well maintained will likely have a leak rate equal to 20 percent of total compressed air production capacity.”

Adjusting data from that 1998 Department of Energy fact sheet to 2013 dollars, a 1/4-in. leak that cost $8,382/year in 1998 would now cost a manufacturer $12,026/year. And that’s not even adjusting for the average kWh rate, which was 5 cents/kWh in 1998 and now averages about ~12 cents/kWh.

The bottom line today is the same as it was in 1998: By simply fixing compressed air leaks in your facility, the impact to your bottom is significant. The real question is: Why is this still an issue today?

Prior to ISO 11011, virtually anybody could offer to provide energy surveys, air audits and data logging of compressed air usage, to no recognized standard, with wildly varying results and findings.
 One possible reason is the lack of standardization around the energy audit process in general and dealing with compressed air leaks, specifically.

In October 2013, ECOskills, an environmental training group based in the U.K., held an event to highlight the new ISO 11011:2013 standard to improve compressed air energy assessments.

Speaking at the event, Stephen Boults, capital equipment manager at Thorite (an independent U.K.-based distributor of compressed air products and process systems), explained that over 10 percent of electricity consumed by British industry is used to generate compressed air, yet many unmanaged systems waste 30-40 percent of the compressed air produced.

“Reducing current energy costs is the main driver for instigating an energy efficiency assessment,” said Boults. “Yet, up to now, virtually anybody could offer to provide energy surveys, air audits and data logging of compressed air usage, to no recognized standard, with wildly varying results and findings.”

By establishing requirements on how to conduct an energy efficiency assessment, ISO 11011 is expected to dramatically change the energy audit process. The standard addresses three aspects of compressed air systems: supply, transmission, and demand.

Boults noted that the standard also covers analysis of the assessment data, how the findings are documented, and how estimates of energy savings can be achieved. The standard also addresses the competency of the assessor as well as the assessment methodology, objectives, and scope of the audit.

“ISO 11011 enables industry to receive accurate assessments of the savings achievable by professional management of compressed air systems and the installation of energy-efficient compressors and controllers,” Boults said. “It's a win-win situation for those companies that implement ISO 11011's new energy efficiency assessments, as less electrical power consumption not only saves money but also cuts carbon emissions too.”

AHU Validation : The Concept

The degree of cleanliness of air in the pharmaceutical manufacturing and related operations area should be established depending on the characteristics of products and operations in the area.

In order to establish and maintain such standards, careful attention has to be exercised to keep the standards from the stage of design and construction through to the monitoring in the stage of routine operations.

Air Quality

A total air handling system, covering the open air intake, treatment, the supply to the manufacturing area, and the exhaust, should be designed and validated. The handling system contains units or prefiltration, temperature and humidity control, final air filtration, return and exhaust. When the air is supplied to the manufacturing area, care is required in maintaining the required air quality during the operation or at the point of product exposure to the environment.

This point is closely related to the layout and construction features of the manufacturing area.

  • The air flow from the critical or most clean area to the surrounding area; that is, the less clean area. For this purpose, rooms used for the manufacturing operation have to be laid out according to the order of the required air cleanliness.

  • In order to maintain the air cleanliness in the area and airflow, the amount of air supplied and exhaust have to be balanced to keep the designed air exchange ratio, airflow pattern, and air pressure differentials. In each room the operation site should be maintained in the most suitable status.


For each purpose, the following items must be carefully controlled.
  • Locations and number of air supplies
  • Locations and number of air exhausts
  • Ratio of air exchange
  • Return ratio of exhaust air
  • Location of local air exhaust, if necessary
  • Airflow pattern at the site of product exposure
  • Air velocity at the point of product exposure


These features have to be well designed, installed, validated, and maintained. Critical operation has to be performed under the unidirectional airflow (laminar airflow). Air turbulence deteriorates air quality by intake of air from surrounding less clean areas.

The amount of air supplied and exhausted is related to the air pressure differentials. After the system is validated, air quality should be continuously monitored and maintained during manufacturing operations.
Filters used for the prefiltration and final filtration should be maintained to operate to their design specifications. Deterioration of filters is caused by leakage and/or accumulation of particles. The former is tested by periodical integrity test (usually dioctylphthalate DOP test), and the latter is tested by the increase of air pressure differentials between the upstream and downstream sides of the filter.

Regulations and Standards

All of the environmentally-controlled areas of pharmaceutical manufacturing and its related areas should meet the requirement of air cleanliness, which is expressed as classification specified by official standards, such as ISO (International Organisation of Standardisation) or FED-STD (U.S federal standard) 209, and/or GMP.