PRODUCT INFORMATION Volumetric instruments

BRAND GMBH + CO KG

P.O. Box 1155

97861 Wertheim (Germany) www.brand.de

BRAND GMBH + CO KG ⋅ Otto-Schott-Straße 25 ⋅ 97877 Wertheim ⋅ Germany

PRODUCT INFORMATION

Volumetric instruments according to USP tolerances

Companies producing pharmaceutical products for the USA market and therefore supervised by US authorities, e.g., the FDA ( F ood and D rug A dministration) have to meet the requirements of the

USP ( U nited S tates P harmacopeia).

The USP describes in section 31 the requirements for glass volumetric instruments. In a footnote it referrers to the N.B.S. Circular ( N ational B ureau of S tandards) 602, Issued April 1, 1959.

This NBS Circular 602 gives detailed design specifications and defines tolerances.

Some details are:

1.

Each instrument should be marked permanently by an individual identification number.

2.

In general, the USP-tolerances are smaller than the DIN specifications of class A/AS.

3.

For volumetric flasks the internal neck diameter should be equal to the inner lower diameter of the ground joint.

4.

For bulb pipettes (Transfer Pipets), measuring pipettes and burettes delivery times of class A are required.

5.

The NBS describes volumetric flasks and measuring cylinders calibrated of >Ex< and >In< with different tolerances.

6.

Burettes with Schellbach stripe are not accepted because of potential errors from parallax.

Discussion of USP requirements:

BRAND volumetric instruments are based on the DIN- and/ or ISO-standards and do not meet all details in construction as mentioned in the USP requirements (NBS circular), which further on are based on the ASTM standards (American Society for Testing and Materials). Anyway, some of these regulations turn out not to be relevant in practice since in the first place it is most important to work according to the demanded tolerances to gain correct and reliable measuring results.

Requirement of an identification number

This requirement is fully accomplished by BRAND volumetric instruments with batch respectively individual certificate, which additionally even allow determining the year of production by the serial number.

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Requirements regarding delivery times

At the time the NBS Circular 602 (1. April 1959) was published, class AS volumetric instruments with short delivery times were not known. BRAND for instance established class AS instruments for the first time in 1964. (A comfortable advantage of class AS pipettes is the enlarged tip opening which is effortlessly to clean and does not become blocked easily.) To comply with the stated tolerances it’s necessary to keep to the specified waiting time. Delivery time and the following waiting time must be seen as an inseparable unit.

As the NBS Circular 602 presently is still in effect unchanged, class AS instruments are neither in the NBS Circular nor in the USP mentioned up to now.

Tolerances requirements

For working practice the most important key parameter of volumetric instruments is the tolerance.

Compared to class A/AS the USP tolerances are slightly narrower for volumetric flasks, narrower for small-volume bulb pipettes and considerably smaller for measuring cylinders.

The USP Certificates for BLAUBRAND ® compliance with USP tolerances.

volumetric instruments issued by BRAND confirm the

Other requirements

The requirement, that the internal neck diameter of volumetric flasks should be equal to the inner lower diameter of the ground joint obviously applies to the uncommon type of volumetric flask which is calibrated to deliver (>EX<).

The statement of a potentially higher error in reading off burettes with Schellbach stripe is barley reasonable and not sustainable.

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BLAUBRAND ® volumetric instruments with USP certificate

Every glass volumetric measuring instrument is individually calibrated. Computer-controlled systems ensure maximum precision in a fully automated production line. The final step of this Statistical

Process Control (SPC) is random finished product sampling according to DIN ISO 3951. The quality management system applied at BRAND and certified to DIN EN ISO 9001 is a combination of process monitoring and random checks. The accepted quality level is at the very least 0.4.

USP Batch certificate for volumetric flasks only*

Each volumetric flask is supplied with one batch certificate per packing of the manufacturer confirming the volume tolerances in compliance with the United States Pharmacopeia (USP 27).

The certificate records the mean volume, the standard deviation of the batch and the date of issue

(batch number: year of manufacture/batch).

USP Individual certificate for all volumetric instruments*

The Volumetric measuring instrument is supplied with an individual certificate confirming the volume tolerance in compliance with the United States Pharmacopeia (USP 27). The certificate records the measured volume, the uncertainty of measurement and the date of issue (individual serial number: year of manufacture/batch/consecutive instrument number).

* USP certificates can not be provided for wide neck volumetric flasks.

Appendix: Table of tolerances

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P.O. Box 1155


In s tru m e n t

O n e - M a rk - P ip e tte









(T ra n s fe r p ip e tte )

G ra d u a te d P ip e tte







B u re t

B u re t

B u re t

B u re t

B u re t

V o lu m e tric F la s k












G ra d u a te d C y lin d e r








BBR - USP - E

BBR - USP - C / E

V o lu m e

0 ,5 m l

1 m l

2 m l

5 m l

1 0 m l

2 0 m l

2 5 m l

5 0 m l

1 0 0 m l

0 ,5 m l

1 m l

2 m l

5 m l

1 0 m l

2 0 m l

2 5 m l

2 m l : 0 ,0 1

5 m l : 0 ,0 1

1 0 m l : 0 ,0 2

2 5 m l : 0 ,0 5

5 0 m l : 0 ,1

5 m l

1 0 m l

2 0 m l

2 5 m l

5 0 m l

1 0 0 m l

2 0 0 m l

2 5 0 m l

5 0 0 m l

1 0 0 0 m l

2 0 0 0 m l

5 0 0 0 m l

5 m l

1 0 m l

2 5 m l

5 0 m l

1 0 0 m l

2 5 0 m l

5 0 0 m l

1 0 0 0 m l

IS O 3 8 5

± 0 ,0 1 m l

± 0 ,0 1 m l

± 0 ,0 2 m l

± 0 ,0 3 m l

± 0 ,0 5 m l

IS O 1 0 4 2

± 0 ,0 2 5 m l

± 0 ,0 2 5 m l

± 0 ,0 4 m l

± 0 ,0 4 m l

± 0 ,0 6 m l

± 0 ,1 m l

± 0 ,1 5 m l

± 0 ,1 5 m l

± 0 ,2 5 m l

± 0 ,4 m l

± 0 ,6 m l

± 1 ,2 m l

IS O 4 7 8 8

± 0 ,0 5 m l

± 0 ,1 m l

± 0 ,2 5 m l

± 0 ,5 m l

± 0 ,5 m l

± 1 m l

± 2 ,5 m l

± 5 m l

T o l. A / A S

D IN 1 2 6 9 1

± 0 ,0 0 5 m l

± 0 ,0 0 8 m l

± 0 ,0 1 m l

± 0 ,0 1 5 m l

± 0 ,0 2 m l

± 0 ,0 3 m l

± 0 ,0 3 m l

± 0 ,0 5 m l

± 0 ,0 8 m l

IS O F D IS 8 3 5

± 0 ,0 0 6 m l

± 0 ,0 0 7 m l

± 0 ,0 1 m l

± 0 ,0 3 m l

± 0 ,0 5 m l

± 0 ,1 m l

± 0 ,1 m l

T o l. A / A S

B B R - U S P - E

± 0 ,0 0 6 m l

± 0 ,0 0 6 m l

± 0 ,0 0 6 m l

± 0 ,0 1 m l

± 0 ,0 2 m l

± 0 ,0 3 m l

± 0 ,0 3 m l

± 0 ,0 5 m l

± 0 ,0 8 m l

B B R - U S P - E

± 0 ,0 1 m l

± 0 ,0 1 m l

± 0 ,0 1 m l

± 0 ,0 2 m l

± 0 ,0 3 m l

± 0 ,0 5 m l

± 0 ,0 5 m l

B B R - U S P - E

± 0 ,0 1 m l

± 0 ,0 1 m l

± 0 ,0 2 m l

± 0 ,0 3 m l

± 0 ,0 5 m l

B B R - U S P - C / E

± 0 ,0 2 m l

± 0 ,0 2 m l

± 0 ,0 3 m l

± 0 ,0 3 m l

± 0 ,0 5 m l

± 0 ,0 8 m l

± 0 ,1 m l

± 0 ,1 2 m l

± 0 ,1 5 m l

± 0 ,3 m l

± 0 ,5 m l

± 1 ,2 5 m l

B B R - U S P - E

± 0 ,0 5 m l

± 0 ,0 8 m l

± 0 ,1 4 m l

± 0 ,2 m l

± 0 ,3 5 m l

± 0 ,6 5 m l

± 1 ,1 m l

± 2 m l

These istruments can only be delivered with USP individual certificate.

The engraved serial number additionally carries the sign "USP".

Volumetric flasks generally can be delivered with USP batch certificate.

"USP" is indicated above the BLAUBRAND® logo on the instrument.

Of course, individual certificates can be issued, too.

0307/ 1

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PRODUCT INFORMATION Volumetric instruments

PRODUCT INFORMATION

Volumetric instruments according to USP tolerances

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PRODUCT INFORMATION Volumetric instruments