[2R-(2α,3Z,5α)]-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, compound with tert-butylamine (1:1)

Guidance on Safe Use

First-aid measures

Ingestion: Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the exposed subject is unconscious or semi-conscious. Wash out the mouth with water. If the exposed subject is fully conscious, give plenty of water to drink. Obtain medical attention.

Inhalation: Using appropriate personal protective equipment, move exposed subject to fresh air. If breathing is difficult or ceases, ensure and maintain ventilation. Give oxygen as appropriate. The exposed subject should be kept warm and at rest. Obtain medical attention in cases of known or possible over exposure, or with symptoms including chest pain, difficulty breathing, loss of consciousness or other adverse effects, which may be delayed.

Skin contact: Using appropriate personal protective equipment, remove contaminated clothing and flush exposed area with large amounts of water. Obtain medical attention if skin reaction occurs, which may be immediate or delayed.

Eye contact Wash immediately with clean and gently flowing water. Continue for at least 15 minutes. Obtain medical attention.

Fire-fighting measures

Fire and Explosion Hazards:

This material is highly flammable.

Dust clouds are potentially extremely sensitive to ignition from incendive electrostatic discharges.

Dust clouds are of very low sensitivity to ignition from hot surfaces.

No ignition or exotherm of a powder layer observed up to 400 °C.

Ignition of a dust cloud produces a strong dust explosion.

High pressure between 8 and 10 bar is produced during a dust explosion.

Suitable Extinguishing Media Water, dry powder or foam extinguishers are recommended. Carbon dioxide extinguishers may be ineffective.

Accidental release measures

Personal Precautions Wear protective clothing and equipment consistent with the degree of hazard. Instruct all personnel not involved in clean-up operations to keep at a designated safe distance. Remove or shut off all sources of ignition.

Environmental Precautions Prevent entry into waterways, sewers, surface drainage systems and poorly ventilated areas. If spill is outdoors, cover with plastic sheet to minimise spreading or contact with rain.

Clean-up Methods: Flush material direct to drain with copious amounts of running water ensuring that at least a ten (10) fold dilution is achieved. Note that concentrated solutions in water may degrade vigorously evolving much heat. This may be a delayed reaction. Under these conditions, sufficient heat may be generated to ignite combustible materials in close proximity to the degrading solution.

Decontamination Procedures The spillage area must be thoroughly washed with copious amounts of water to ensure that all traces of material are flushed to drain with at least a ten (10) fold dilution. The waste waters generated during decontamination should be directed to a waste water treatment system.

Handling and storage

PRECAUTIONS FOR SAFE HANDLING

GSK Process Hazard Category 4

General Requirements :

Avoid dispersion as a dust cloud.

Depending upon the scale of operation, use of appropriate exhaust ventilation is recommended to provide routine control of fire and explosion hazards during handling of this material.

Ignition Controls: Any mechanical operations used for particle size reduction should be performed in a manner that do not produce localised heating.Bond and earth (ground) all plant and equipment to ensure that no isolated conductors are present. Isolated conductors can accumulate sufficient electrostatic charge to produce discharges of many hundreds of milli-Joules. Consider earthing (grounding) personnel dealing with dusty operations. An isolated (insulated) human body can readily produce electrostatic discharges in excess of 50 mJ, but have been recorded up to 100 mJ.

Minimise the use of plastics when handling this material. Handle and store this material only in conductive or anti-static plastic liners (bags) since normal plastics are known to be capable of producing electrostatic discharges of up to 4 mJ, ensuring that any containers into which they are placed are themselves of a conductive material and earthed (grounded). Due to the very low minimum ignition energy for this powder, it is advisable to treat this material as if it is a flammable solvent vapour.

The maximum surface temperature of enclosures potentially exposed to this material should be the lower of the values obtained by taking 2/3 of the minimum ignition temperature for a dust cloud or 75 K less than the minimum ignition temperature of the dust layer, with a maximum temperature of 325 °C.

Protective Systems:

Assess operations based upon available dust explosion information to determine the suitability of preventive or protective systems as precautionary measures against possible dust explosions. If prevention is not possible, consider protection by use of containment, venting or suppression of dust handling equipment. Where explosion venting is considered the most appropriate method of protection, vent areas should preferably be calculated based on the Kst rather than the St value. If nitrogen purging is considered as the protective system, it must operate with an oxygen level below the limiting oxygen concentration. The system should include an oxygen monitoring and shut-down facility in the event of excessive oxygen being detected.

At both ambient and low humidity, this material is of low conductivity. Generation of electrostatic charge is considered likely to occur even when handled in an earthed (grounded) environment. At ambient humidity, this material has a fast charge relaxation time. Accumulation of electrostatic charge is considered unlikely to occur when handled in an earthed (grounded) environment. At the end of the charge accumulation process charge is expected to be readily lost to earth (ground) At low humidity, this material has a long charge relaxation time. Accumulation of electrostatic charge is considered likely to occur even when handled in an earthed (grounded) environment. Under these conditions, it is considered that this material might present a very high risk of producing an electrostatic discharge.

CONDITIONS FOR SAFE

STORAGE

Quality tested material with a moisture content of less than 0.5% must be stored in maximum aliquots of 25 Kg at a maximum temperature of 25 degrees C for less than two weeks. Longer term storage must be at a maximum temperature of 5 degrees C. Material containing more than 0.5% water must be reprocessed. Storage outside of these limits may initiate an exothermic reaction.

The material should be stored in a dry, lacquered, conducting steel drum with welded seams containing two conducting polythene liners (bags) of a quality approved for use with pharmaceuticals. The inner liner is filled as required and sealed, followed by the sealing of the outer liner. For storage of 30 days or more, a 225 g sachet of molecular sieve desiccant (grade 3A) must be placed on top of the outer liner. The drum should only be sealed with the lid and associated clip once the moisture content is known to be within specification. Keep away from moisture. Keep away from light. Store away from sources of ignition.

Transport information

Land transport (UN RTDG/ADR/RID)

UN number:

UN 3088

Shipping

Labels:

4

SpecialProvisions

Inland waterway transport (UN RTDG/ADN(R))

UN number:

UN 3088

Shipping

Labels:

4

Remarks

Marine transport (UN RTDG/IMDG)

UN number:

UN 3088

Shipping information

Proper shipping name and description:

Self-heating solid, organic, nos

Chemical name:

TERTIARY BUTYLAMMONIUM CLAVULANATE

Labels:

4

Remarks

Air transport (UN RTDG/ICAO/IATA)

UN number:

UN 3088

Shipping information

Proper shipping name and description:

Self-heating solid, organic, nos

Chemical name:

TERTIARY BUTYLAMMONIUM CLAVULANATE

Labels:

4

Remarks

SpecialProvisions

Exposure controls / personal protection

ENGINEERING CONTROLS

Exposure Controls: An Exposure Control Approach (ECA) is established for operations involving this material based upon the OEL/Occupational Hazard Category and the outcome of a site- or operation-specific risk assessment. Refer to the Exposure Control Matrix for more information about how ECA's are assigned and how to interpret them.

Containment: No special engineering controls are required.

Ventilation: Local exhaust ventilation (LEV) is recommended.

Administrative:  Only authorised personnel may enter the working area.

PERSONAL PROTECTIVE EQUIPMENT

Eye Protection:

Wear approved safety glasses with side shields or cover goggles if eye contact is possible.

Gloves:

The selection of gloves for a specific activity must be based on the material's properties and on possible permeation and degradation that may occur under the circumstances of use. Glove selection must take into account any solvents and other hazards present. Potential allergic reactions can occur with certain glove materials (e.g. Latex) and therefore these should be avoided. Care must be exercised if insufficient data are available and further guidance should be sought from your local EHS department.

Respirators: If respiratory protective equipment (RPE) is used, the type of RPE will depend upon air concentrations present, required protection factor as well as hazards, physical properties and warning properties of substances present. Follow local regulations for respirator use in the workplace.

Other Equipment or Procedures: An eye wash station should be available

Stability and reactivity

Chemical Stability: This material is unstable at elevated temperatures and in contact with moisture.

Conditions to Avoid: Avoid direct sunlight, conditions that might generate heat and dispersion as a dust cloud.

Incompatible Materials: Water.

Disposal considerations

Disposal Recommendations:

Collect for recycling or recovery if possible. Reject material, unsuitable for recovery, should be disposed by dissolving in sufficient water to produce a solution concentration of less than ten % weight volume (10% w/v) of potassium clavulanate/TBA clavulanate and discharging to effluent. Keg liners (bags) and other disposable packaging and cleaning materials must be thoroughly washed free of any product residues (whether undiluted TBA clavulanate or blend) using copious amounts of water prior to disposal as non-hazardous waste. Always use sufficient water to ensure that the concentration of material never rises above ten % weight volume(10% w/v). Do not use a dunk tank for washing successive components unless procedures precisely detail how often the water should be renewed. Sieve residues should normally be regarded as non-recoverable reject material and treated as hazardous waste.

Regulatory Requirements Observe all local and national regulations when disposing of this material.