Logo
OptiLube Zero 5g Sachets Box of 150

OptiLube Zero 5g Sachets Box of 150

OptiLube Zero

Injection & Infusion
  • CE Marked medical device with CE mark 0483, indicating conformity assessment by a notified body.
  • Class IIa sterile lubricating jelly medical device (as per general classification for OptiLube sterile lubricating jelly range).
  • Supplied sterile and sterilised using moist heat after packaging, with single sterile barrier system plus protective packaging.
  • Validated by Hologic for use with the ThinPrep Pap Test when used as instructed.
  • Manufactured under quality management systems applicable to medical devices by Sion Biotext Medical Ltd and distributed by Optimum Medical Solutions Ltd.
Sterile lubricating jelly \u2013 carbomer/paraben/chlorhexidine-free 5g single-use sachets

Description

OptiLube Zero 5g Sachets (product code 1170) are sterile, clear, water-soluble lubricating jelly sachets that contain zero carbomers, zero parabens and zero chlorhexidine. Supplied as a box of 150 single-use 5g sachets, OptiLube Zero is designed to provide optimal lubrication to aid the smooth insertion of medical devices during a wide range of diagnostic and therapeutic procedures, while supporting best-practice infection prevention through individual patient-use packaging.

Bnefits

  • Carbomer-free, paraben-free and chlorhexidine-free formulation, reducing exposure to these excipients while maintaining effective lubrication.
  • Sterile, clear, colourless, non-sticky, non-greasy and non-staining gel that is non-irritating to the skin, improving patient comfort.
  • Water-soluble, high-viscosity gel that spreads easily, adheres well to instruments and is easily rinsed off with water after procedures.
  • Single-use 5g sachets designed for individual patient use promote increased infection control and reduce risk of patient-to-patient cross-contamination.
  • Individually packed sachets help reduce product waste compared to multi-use tubes, as only the required amount is opened for each patient.
  • Use of sterile lubrication during diagnostic and therapeutic procedures has been shown to increase patient comfort, reduce the risk of trauma and reduce the risk of infection.
  • Validated by Hologic for use with the ThinPrep Pap Test when used as instructed, supporting safe use in cervical screening and gynaecological procedures.
  • Supplied sterile and sterilised by moist heat after packaging, with clear IFU and labelling for professional hospital and clinical use.
  • Compatible with a wide range of medical devices, including catheters, endoscopes, surgical instruments and gynaecological and rectal devices.
  • Distributed globally by Optimum Medical Solutions with support materials and IFU available, ensuring traceability and regulatory compliance.

Indications

  • Intended to lubricate body orifices to assist insertion of medical devices for diagnostic and therapeutic purposes.
  • Typical uses include insertion of urinary catheters, endoscopes, surgical instruments and specula.
  • Suitable for gynaecological, rectal and oral procedures and examinations where a sterile water-soluble lubricant is required.
  • Intended users include patients, their carers and healthcare professionals, in hospital and professional clinical settings.
  • Validated for use with the ThinPrep Pap Test when used as instructed.

Composition

  • Processed (purified) water.
  • Hydroxyethyl cellulose QP-100 MH (gelling agent).
  • Sodium hydroxide 20% (pH adjustment).
  • Sodium benzoate (preservative).
  • Sodium EDTA (chelating agent).
  • Propylene glycol (humectant).
  • Glycerine (humectant).
  • Polysorbate 20 (surfactant/emulsifier).
  • Lactic acid.
  • Formulated with zero carbomers, zero parabens and zero chlorhexidine.

Formulation

  • Sterile lubricating jelly, clear, colourless, water-soluble, high-viscosity gel-like liquid.
  • Non-sticky, non-greasy, non-staining and non-irritating lubricant to the skin.
  • Water-based formulation designed for use as a lubricating medium for insertion of medical instruments during medical procedures.
  • Easily rinsed off with water after use.
  • Supplied as a 5g single-use sachet for individual patient use.

Packaging

  • Box containing 150 single-use 5g sachets of OptiLube Zero lubricating jelly.
  • Each sachet is an individual sterile barrier system, to be opened immediately before use.
  • Product code: 1170; described as OptiLube Zero 5g sachet.
  • Supplied sterile and sterilised by moist heat after packaging.
  • Outer carton carries product identification, batch number, expiry date, CE mark and relevant symbols; sachets are easy to tear for quick application.

Usage

  • OptiLube Zero sachets are sterile and single-use; verify that the sachet and outer packaging are intact and within the expiry date before use.
  • Do not use the sachet if it is torn, damaged or cut, or if there is any doubt about sterility.
  • Tear the sachet open at one end along the indicated tear line.
  • Squeeze the sachet to obtain the desired amount of lubricating jelly.
  • Apply the gel directly to the medical device and/or to the relevant body orifice, as required for the procedure.
  • Proceed with insertion of the medical device in line with local clinical protocols and the device manufacturer’s instructions.
  • Avoid contact with eyes and ears; if accidental contact occurs, rinse thoroughly with water and seek medical advice if irritation persists.
  • Discard any unused gel remaining in the sachet after the procedure; do not reuse or attempt to resterilise the sachet.
  • After the procedure, excess gel may be gently wiped away and, if needed, rinsed off with water.
  • Dispose of used sachets and any associated consumables according to local clinical waste policies and procedures.

Contraindications

  • Do not use if the sachet is torn, damaged or cut, or if sterility is compromised.
  • Do not use in patients with known hypersensitivity or allergy to any of the ingredients (e.g. sodium benzoate, propylene glycol, glycerine, polysorbate 20 or other excipients).
  • Avoid contact with eyes and ears; if this occurs accidentally, rinse thoroughly with water and seek medical advice if irritation persists.
  • Re-use of this single-use medical device is contraindicated, as it may result in infection and/or cross-contamination.
  • Resterilisation, reprocessing, cleaning or disinfection of the sachet or contents is contraindicated, as it may compromise product characteristics and result in trauma or infection.

Adverse Effects

  • There are no known common side effects when used as directed.
  • In rare cases, local irritation or hypersensitivity reactions may occur, with symptoms such as redness, itchiness or blistering at the site of application.
  • If signs of irritation or hypersensitivity occur, discontinue use immediately and consult a healthcare professional.
  • Any serious incident related to the device should be reported to the manufacturer and to the competent authority in the user’s country.

Storage Conditions

  • Store at room temperature as indicated in the IFU.
  • Keep dry and out of direct sunlight.
  • Avoid excessive heat and humidity during storage and transport.
  • Do not use after the labelled expiry date.
  • Keep out of reach of children.
  • Do not use if the package is damaged; consult the instructions for use if there are any concerns about storage or handling conditions.

Duration

Not applicable; OptiLube Zero is used as a single-use lubricating aid during individual diagnostic or therapeutic procedures rather than over a defined treatment course.

Onset

Immediate lubricating effect upon application to the medical device and/or body orifice.

Browse more Injection & Infusion

Top Treatments

Top Cities in the UK