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OptiLube Zero Sterile Lubricating Jelly 5g Sachets

OptiLube Zero Sterile Lubricating Jelly 5g Sachets

OptiLube Zero

Medical device
  • CE Marked sterile medical device (CE Certification Mark indicated on IFU and packaging).
  • Manufactured under a quality system compliant with medical device regulatory requirements (manufacturer specialises in medical devices and supplies).
  • Validated by Hologic for use with the ThinPrep Pap test when used as instructed (as stated in the IFU).
  • Sterilised by moist heat after packaging, with labelling for single sterile barrier system and non Reuse.
  • Manufacturer (Optimum Medical Solutions Ltd) operates as a specialist healthcare manufacturer in urology and healthcare lubrication and holds relevant quality and sustainability certifications at company level (e.g. Toitū Carbon Reduce Organisation certification).
Sterile lubricating jelly / water-based medical lubricant

Description

OptiLube Zero is a sterile, clear, colourless, high-viscosity, water-soluble lubricating jelly supplied in single-use 5g sachets. It has been specifically formulated with zero carbomers, zero parabens and zero chlorhexidine (CHG), making it suitable for patients with sensitivities to these ingredients. The gel is non-sticky, non-greasy, non-staining and non-irritating to the skin, and is designed to provide optimal lubrication to aid the smooth insertion of medical devices during a wide range of diagnostic and therapeutic procedures. OptiLube Zero is validated by Hologic for use with the ThinPrep Pap test (when used as instructed) and is intended for hospital and professional use in both general and gynaecological examinations, as well as other procedures requiring a sterile, water-based lubricant.

Bnefits

  • Sterile, single-use 5g sachets promote infection control and reduce the risk of patient-to-patient contamination.
  • Water-soluble, clear, non-greasy, non-sticky formulation for comfortable use and easy rinsing with water.
  • Contains no carbomers, parabens or chlorhexidine (CHG), helping minimise the risk of reactions in sensitive patients.
  • Provides optimal lubrication to aid smooth insertion of medical devices and reduce friction-related trauma.
  • Helps increase patient comfort during and after diagnostic and therapeutic procedures.
  • Helps reduce the risk of trauma and infection associated with dry insertion of devices.
  • Non-staining and non-irritating to the skin when used as directed.
  • Validated by Hologic for use with the ThinPrep Pap test when used according to instructions.
  • Single-patient, single-use sachet format can reduce product waste compared with multi-use containers.
  • Supplied by a specialist urology and healthcare lubrication manufacturer whose products are widely used in NHS hospitals and internationally.

Indications

  • Lubrication of body orifices to aid insertion of medical devices for diagnostic and therapeutic purposes.
  • Insertion of urinary catheters.
  • Insertion of endoscopes and other surgical instruments.
  • Gynaecological procedures, including speculum insertion and cervical sampling (including ThinPrep Pap test where validated).
  • Rectal examinations and procedures.
  • Oral and pharyngeal procedures where a water-based sterile lubricant is appropriate.
  • Insertion of rubber or plastic medical devices requiring lubrication.
  • General use as a sterile lubricating jelly for hospital and professional procedures where a carbomer-, paraben- and chlorhexidine-free formulation is desired.

Composition

  • Processed water (purified water/aqua).
  • Hydroxyethyl cellulose QP-100 MH.
  • Sodium hydroxide 20%.
  • Sodium benzoate.
  • Sodium EDTA (disodium EDTA).
  • Propylene glycol.
  • Glycerine (glycerol).
  • Polysorbate 20.
  • Lactic acid.

Formulation

  • Sterile, clear, colourless, high-viscosity gel-like liquid.
  • Water-soluble, non-greasy, non-sticky and non-staining.
  • Non-irritating lubricant to the skin when used as directed.
  • Free from carbomers, parabens and chlorhexidine (CHG).
  • Supplied as a single-use, gamma/steam-sterilised medical device (sterilised by moist heat after packaging).
  • Intended for hospital and professional use as a lubricating jelly for medical procedures.

Packaging

  • 5g sterile sachets (product code 1170) intended for single use.
  • Sachets supplied in boxes typically containing 144 or 150 sachets, depending on distributor (e.g. box of 150 for some UK suppliers).
  • Each sachet is individually sealed and sterile until opened, designed for individual patient use.
  • External cartons carry standard medical device labelling including batch number, use-by date, temperature limits, and CE mark.
  • Packaging designed to be easy to tear open to facilitate aseptic handling during procedures.

Usage

  • Ensure the product is within its expiry date and the sachet packaging is intact (not torn, damaged or cut) before use.
  • Confirm suitability of OptiLube Zero for the intended procedure and compatibility with any medical devices to be used.
  • Prepare the site and medical device according to local clinical guidelines.
  • Open the sachet by tearing at one end along the indicated tear or notch, using aseptic technique where required.
  • Squeeze the sachet to obtain the desired amount of lubricating jelly.
  • Apply the jelly directly to the medical device (e.g. catheter, speculum, endoscope, instrument) and/or to the body orifice as required.
  • Proceed with the diagnostic or therapeutic procedure, reapplying jelly as needed during the same procedure.
  • Avoid contact with eyes and ears; do not inject the product.
  • After use, discard the empty sachet and any remaining gel; do not reuse.
  • Dispose of used sachets and any associated materials according to local clinical waste policies.

Contraindications

  • Known hypersensitivity or allergy to any of the ingredients (e.g. hydroxyethyl cellulose, propylene glycol, glycerine, polysorbate 20, sodium benzoate, lactic acid or other listed excipients).
  • Do not use if the sachet is torn, damaged or has been previously opened, as sterility may be compromised.
  • Not for use in or around the eyes or ears.
  • Not for injection or for use in applications contrary to local clinical guidelines.
  • Re-use of the device is contraindicated; reuse may result in infection or cross-contamination.

Adverse Effects

  • No known common side effects when used as directed.
  • In rare cases, local irritation or hypersensitivity may occur, with symptoms such as redness, itchiness, burning or blistering at the application site.
  • If signs of irritation or hypersensitivity occur, stop using OptiLube Zero 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, in line with IFU guidance.

Storage Conditions

  • Store at room temperature within the temperature limits indicated on the packaging (generally ambient conditions).
  • Keep dry and out of direct sunlight.
  • Avoid excessive heat and humidity.
  • Keep out of the reach of children.
  • Do not use after the expiry date printed on the sachet/carton.
  • Discard sachet after single use; do not attempt to resterilise or reuse.

Duration

Applied immediately before and/or during the relevant diagnostic or therapeutic procedure; single-use per sachet and per patient, with reapplication permitted during the same procedure as needed.

Onset

Immediate lubricating effect upon application to the device and/or tissue.

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