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May/June 2009

ASTM International Standards in Latin America

Considering Three Cases

Nations across Central America, South America and the Caribbean use ASTM International standards as a common language in commerce that help ensure safety and quality. For this article, three ASTM members, from Peru, Mexico and Colombia, provided a glimpse of the use of standards for biofuels, pharmaceuticals, and concrete in their countries.

Biofuel Standards in Peru

This year, according to legislation enacted in Peru, all diesel fuel must contain 2 percent biodiesel, a requirement that will increase to 5 percent biodiesel in 2010. In addition, a proportion of 7.8 percent ethanol must be part of gasoline composition next year. To ensure the quality and efficacy of biofuels, the country has adopted a national biodiesel standard in 2008 that references ASTM D6751, Specification for Biodiesel Fuel Blend Stock (B100) for Middle Distillate Fuels, which delineates the biofuel property requirements — from flash point and cloud point to cold soak filterability and sulfur content.

The Peruvian technical committee on biofuels, according to committee coordinator Ricardo Díaz Baron, investment promotion officer at ProInversion, Lima, Peru, and a member of Committee D02 on Petroleum Products and Lubricants, is also preparing a technical standard on ethanol that it expects to introduce this year. That proposed standard cites ASTM D4806, Specification for Denatured Fuel Ethanol for Blending with Gasolines for Use as Automotive Spark-Ignition Engine Fuel, which also details performance requirements.

Peru is currently promoting investments in the production of biofuels from sugar cane, sorghum, palm oil and, more recently, cellulosic ethanol and algae. Díaz notes that the nation “is actively promoting these investments in order to develop rural areas and reduce poverty.”

To further assist in the understanding of ASTM fuel standards and their use, the society recently held two special sessions. A conference in Lima, Peru, included a presentation about ASTM fuel standards and related programs followed a month later with a videoconference during which Peruvian petroleum industry representatives asked questions related to ASTM biodiesel standards.

The impact of ASTM International petroleum-related standards is broader than just biofuels, according to Díaz. “We use ASTM standards for reference in diesel, gasoline and several other additives, oil derivates and laboratory tests,” Díaz says. “Our liquid fuels and oil derivates technical committee is very active because diesel and gasoline standards have a huge impact in the Peruvian economy.”

Pharmaceutical Standards in Mexico

ASTM International standards from Committee E55 on Manufacture of Pharmaceutical Products are acknowledged as the source for acceptance criteria in studies of rating systems, equipment, installation and validation of pharmaceutical processes.

That’s according to Elizabeth Martínez Flores, director general of Terra Farma Group in Mexico City, Mexico, and an ASTM International member since 2006 who works on E55 as well as Committees E11 on Quality and Statistics and E48 on Biotechnology. She oversees the training, consulting and materials sales for industry throughout Latin America for Terra Farma, which consists of four firms that provide consulting services to industrial manufacturing.

Pharmaceutical and biotechnology formed the initial cornerstones for Terra Farma’s work, according to Martínez Flores, who notes two ASTM standards in this area that are particularly useful:

  • E2500-07, Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, and
  • E2537, Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing.

The E2500 standard applies to all elements of pharmaceutical and biopharmaceutical manufacturing, and is intended to satisfy international regulatory expectations that such systems and equipment are fit for their intended use. E2537 describes the continuous quality verification approach to process validation where the manufacturing process is continuously monitored, evaluated and, if necessary, adjusted.

Martínez Flores, who values the professional growth and experience offered by being an ASTM member, also finds ASTM International standards to be useful in training courses and in consulting, mainly in the area of validation. Standards, she says, allow her to keep abreast of competition as well as on top of scientific advances that in turn enable Terra Farma’s clients to keep up to date and to satisfy regulatory expectations.

Concrete Standards in Colombia

Concrete is among the most common building materials in Colombia, according to Manuel Lascarro, director of special projects for ASOCRETO, the Colombian Ready Mixed Concrete Producers Association based in Bogotá. A former member of the ASTM International board of directors, and a member of Committees C09 on Concrete and Concrete Aggregates and E60 on Sustainability, Lascarro says, “Concrete is used in construction from low-income houses to main infrastructure projects, passing through architectural concrete in houses, institutional buildings and bridges.”

In his country, Lascarro adds, 850 of the standards of ICONTEC (Instituto Colombiano de Normas Técnicas y Certificación), the national standardization body, are based on or are related to ASTM standards. For that reason, it is very important to provide the technical experts of Colombia with background on the development of ASTM standards, which will allow for better local adoption of those standards. Since 2001, that access to the ASTM process has been provided through several avenues such as the memorandum of understanding program, workshops and modern electronic tools like virtual meetings and electronic balloting.

The Latin American concrete and concrete aggregates sector has been very active in using these tools. But, it’s a two-way street, Lascarro says. The cooperation has led Colombian engineers to participate in ASTM subcommittees such as those developing new standards for testing self-consolidating concrete.

Lascarro also notes the ASTM Online Centers program, which was developed in partnership with concrete associations in eight countries — Argentina, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Panama and Venezuela — and which provides access to the latest ASTM standards. This helps ensure that state-of-the-art technology as described in ASTM standards will facilitate local standards adoption. The Online Centers also promote virtual training: In March, a virtual presentation with Nicholas Carino, past chairman of Committee C09, about nondestructive testing for concrete, attracted more than 150 experts in Latin America as a proof of the interest in the technical exchange.

A Final Note

ASTM standards play roles in other key industry sectors, and with its strong outreach program, ASTM International looks forward to continued collaboration in Central and South America and the Caribbean. (For an overview of and statistics about ASTM International outreach in Central and South America and the Caribbean, click here.)