Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Close this folder6. Laboratory services
Close this folderNational laboratories for drug quality surveillance and control1
View the document1. Introduction
View the document2. First-stage laboratory for drug surveillance
Close this folder3. Medium-size drug control laboratory
View the document3.1 Capability
View the document3.2 Premises
View the document3.3 Staff
View the document3.4 Equipment
View the document4. Scope of activity
View the document5. Factors influencing the size and location of a laboratory
Open this folder and view contents6. Implementation of control laboratory projects
Open this folder and view contentsGood laboratory practices in governmental drug control laboratories1
Open this folder and view contentsSampling procedure for industrially manufactured pharmaceuticals1
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 
3.4 Equipment

The general laboratory equipment, together with items required in the chemical unit, are listed in Table 2. Water demineralizers and distillation stills are always needed, but their number or capacity can be reduced if a reliable supply of demineralized or distilled water is available from an outside source.

Major items of equipment required for the instrumental unit and for testing of dosage forms, as well as the equipment required for the microbiological unit are also listed in Table 2. Advice on the required performance of many of these instruments is included in The international pharmacopoeia.2

2The international pharmacopoeia, 3rd ed. Volume I. General methods of analysis. Geneva, World Health Organization, 1979. Volume 2. Quality specifications. Geneva, World Health Organization, 1981.

It is essential to ensure, before major items of equipment are purchased, that facilities are available for their proper maintenance and repair, preferably by representatives of the manufacturer. Electrical equipment must be compatible with the existing frequency and line voltage. Standard sets of replacement parts required for running repairs, containing such items as gaskets and spare bulbs, should always be retained in stock. Certain types of equipment, including gas-liquid and high-pressure liquid chromatographs and atomic absorption spectrophotometers, require a constant supply of special solvents, reagents, and compressed gases of high purity. It is essential that the availability of these is also ascertained before purchase. It can be helpful in selecting apparatus to seek information on the performance of instruments from other laboratories, particularly within the same region.

Table 2. Medium-size control laboratory

General laboratory equipment

No.

Microbalance (five-place)

1

Analytical balance (four-place)

2

Laboratory balance (top-loading)

1-2

Refrigerator (with freezer compartment)

2-3

Water distillation still (10 litres/hour)

1

Water deionizing equipment (10 litres/hour)

1

Drying oven

2-3

Muffle furnace

1

Vacuum oven

1

Heating plates with magnetic stirrers

3-4

Vacuum rotary evaporator

1-2

Water-bath (electrical)

2-3

Automatic titrimeter

1

Shaker (wrist-action)

1

Micro-Kjeldahl equipment

1

Equipment for thin-layer chromatography including

 
 

- spreader

1

 

- spotting equipment

1

 

- developing chambers

10

 

- spraying bottles

6

 

- UV viewing lamps

3

Laboratory centrifuge (floor model)

1

Ultrasonic cleaner

2

Vortex mixers

2

Heating mantles for flasks (assorted sizes)

6

Variable transformers

5

Vacuum pump (rotary, oil)

2

Micrometer calipers

1

Glove box

1

Sieves (set)

2

Microscope

1-2

   

Major instruments

 
   

IR spectrophotometer (recording, grating)

1

UV/visible recording spectrophotometer

1

UV/visible spectrophotometer

1

Gas chromatograph

1

Polarimeter (manual)

1

Refractometer

1

pH-meters (with electrodes)

2

Melting-point apparatus (electrically heated)

1

Disintegration test equipment

1

Dissolution test equipment (for 6 tablets/capsules)

1

Penetrometer

1

IR hydraulic pellet press with dies (15 tons/in2 pressure ≈ W 23 × 107 Pa)

1

Agate mortar with pestle

1

Karl-Fischer titrator

1

Oxygen flask combustion apparatus

1

   

Optional items

 
   

Ice machine

1

Solvent recovery apparatus

1

Flame photometer or atomic absorption spectrophotometer

1

Osmometer

1

Vibrospatula

1

High-pressure liquid chromatograph

1

Densitometer for TLC plates

1

Fluorometer (filter)

1

Hardness tester

1

Friability tester

1

Viscosimeter

1

   

Equipment for microbiology unit

 
   

Autoclaves

2

Microscopes (bacteriological)

2

Incubators*

2-3

Centrifuge with refrigeration

1

Membrane filter assembly for sterility tests

 

Colony counter with magnifier

1

Laminar flow bench

1

Hot-air sterilizer

1

Spectrophotometer, visible range (simple model)

1

Nephelometer (+ turbidimeter)

1

Refrigerators

2

Deep freezer

1

Large-plate microbiological assay equipment, including zone reader and recorder

1 set

pH-meter

1

Cleaning machines for glassware, especially one for cleaning pipettes

2

Water-baths (thermostatically controlled)

2

* Cooling incubators in countries with tropical climates

Requirements for glassware and general laboratory apparatus will vary from case to case and cannot be specified in general terms. Provision must be made for an adequate reserve. Lists of reagents to be held in stock are included in The international pharmacopoeia.

Additional equipment will be required if the basic range of tests is extended. Thus, pyrogen testing necessitates provision of animal housing, restraining harnesses or boxes, and a temperature-recording device with probes. An osmometer is required for testing large-volume parenteral preparations.

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