Glove Integrity – A Key Issue in Pharmaceutical Industry

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In the recent past, FDA has issued numerous warning letters to Pharmaceutical Industry with respect to issues relating to data integrity and glove integrity. Pharmaceutical manufacturers will normally require sterile gloves, they also require the gloves to be low particulates, especially if they are making Injectable. There are many ways that particles get on the gloves. The main origin of the particles is human cells, followed by tiny fibers from clothing. Traditionally gloves are packed in paper inner wallets which are then, traditionally, sealed into paper pouches that have a tendency to shed particles when peeled open.

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Sterile cleanroom gloves are packed using non-particulating materials such as polyethylene inner wrappers and easy-to-tear pouches. Gloves shall be manufactured from compounded natural or Nitrile rubber or polychloroprene rubber latex, or thermoplastic elastomer solution, or compounded styrene-butadiene rubber emulsion. To facilitate donning the gloves, any surface treatment, lubricant, powder or polymer coating may be used subject to compliance with ISO 10993.

There are two types of glove used in Pharmaceutical applications as below:

Type-1: The gloves compounded primarily from natural rubber latex.

Type-2: The gloves compounded from a rubber cement or from synthetic rubber latex. Synthetic includes nitrile rubber latex, polychloroprene rubber latex, styrene-butadiene rubber solution, styrene-butadiene rubber emulsion or thermoplastic elastomer solution.

 Any rubber polymer compound that permits the glove to meet the requirements of the specification. A lubricant that meets the current requirements of the U.S. Pharmacopeia for Absorbable Dusting Powder may be applied to the glove. Other lubricants may be used if their safety and efficacy have been previously established. The inside and outside surface of the rubber surgical gloves shall be free of talc.

Design of Gloves

The designs of the glove are classified into two type:

  1. gloves with straight fingers and
  2. gloves with fingers curved in the palmar direction.

The glove shall be anatomically correct, with the thumb positioned towards the palmer surface of the index finger rather than lying flat.

Finishes of Gloves

There are four finishes of glove are classified as below:

  1. Textured surface over part or all of the glove.
  2. Smooth surface
  3. Powdered surface: A powder has been added as a part of the manufacturing process, generally to facilitate donning.
  4. Powder-free surface: The gloves are manufactured without the deliberate addition of powdered materials to facilitate donning.

Glove Regulations

Medical gloves currently are in Class I. The FDA is considering reclassifying medical gloves from Class I to Class II, subjecting them to additional testing and controls. This would include limiting powder and protein, labeling the actual levels of powder and protein and expiration dating.

Surgical glove manufacturers also are required to meet the Current Good Manufacturing Practices (cGMP) regulation for medical devices (21 CFR 820), which includes establishing and maintaining control procedures to ensure that the gloves’ specified design requirements consistently are met.

  • The minimum standards for surgical gloves that must be met are listed in the American Society for Testing and Materials’ (ASTM) “Standard Specification for Rubber Surgical Gloves” (D3577).
  • ASTM standard describes requirements for sterility, freedom from holes, physical dimensions and property characteristics and recommended maximum protein and powder limits. Other optional tests can provide further information on how the gloves will perform.

USFDA approaches on medical gloves:

  • The prevalence of human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS), and its risk of transmission in the health care context, have caused the FDA to look more closely at the quality control of barrier devices, such as surgeon’s gloves and patient examination gloves (collectively known as medical gloves) to reduce the risk of transmission of HIV and other blood-borne infectious diseases.
  • The Centers for Disease Control (CDC) recommendation that healthcare providers wear medical gloves demonstrates the proposition that devices labelled as medical gloves purport to be and are represented to be effective barriers against the transmission of blood-and-fluid-borne pathogens.

USFDA – gloves test methods & defects:

    • General Test Method: FDA’s analysis of gloves for leaks and visual defects will be conducted by a visual examination and by a water leak test method, using 1000 ml of water.
    • Units Examined: Each Medical glove will be analyzed independently. When packaged as pairs, each glove is considered separately, as both gloves will be analyzed.

Defects

Factors for counting defects:

  1. One defect in one glove is counted as one defect.
  2. A defect in both gloves in a pair of gloves is counted as two defects.
  3. If multiple defects are found in one glove, they are counted as one defect.
  4. Visual defects and leaks that are observed in the top 40 mm of a glove will not be counted as a defect for the purpose of the factors for defects.

Identification of Defects:

Defects include leaks detected when tested in accordance with relevant procedure. A leak is defined as the appearance of water on the outside of the glove. This emerge of water from the glove constitutes a watertight barrier failure. Other defects in the glove includes:

    • Tears / Embedded foreign objects
    • Extrusions of glove material on the exterior or interior surface of the glove
    • Gloves that are fused together so that individual glove separation is impossible.
    • Gloves that are adhere to each other and tear when separated, or other visual defects that are likely to affect the barrier integrity.

Visual defects examination:

  • Visually examined each glove for defects. A visual defect observed in the top 40 mm of a glove will not be counted as a defect for the purpose of the examination.
  • Visually defective gloves do not require further testing, although they must be included in the total number of defective gloves counted for the sample. Gloves are tested to determine the Acceptable Quality Level (AQL) of the product as per ISO 2859-1. European AQL standards for examination and surgical gloves are set at a minimum AQL of 1.5. Gloves allow for performing testing and for easy access to the process. Due to their nature, thin plastic, highly flexible and their risk of puncture or rupture, they are regarded as one of the main potential sources of contamination. Gloves are used as a tight but flexible interface for process intervention or performing sterility or other analytical testing. In order to fully maintain the integrity of the whole system, the process, and the protection of the personnel and environment. Thus it is indispensable to check glove integrity routinely to avoid contamination on both sides of the interfacing plastic glove.Gloves provide smooth handling for operations with ampoules, needles, syringes, vials, tubing, filling needles, and for cleaning. This makes them become a critical weak point. Glove thickness is mostly well below 1 mm. Contact with sharp edges, for example, needles or scissors, and the continuous flexing and exposure to chemicals such as hydrogen peroxide, involve a major risk of defects.Glove Integrity Test Methods:1. Flow Test The water breakthrough test is similar to the flow test, but utilizes water pressure to inflate the glove. Visual inspection of the glove to recognize penetrated water droplets allows the localization of a leak. In particle penetrating test, a high-particle or aerosol concentration is applied to challenge one side of the glove. By scanning the other surface side with a particle counter probe, leaks can be detected by raised particle counts around these areas.
  • Visible holes and flaking were observed in the gloves purporting to be sterile. In intact glove packages examined for the integrity of the gloves inside, our investigators found the gloves to have visible holes, flaking, cracking, and /or discoloration.
  • Gloves are worn during critical interventions such as making aseptic connections, clearing jams, clearing fallen vials, sterile primary and secondary closures, purging filling needles, adjusting equipment, and changing environmental monitoring plates. Because of gloves are worn during these critical interventions, using non-integral gloves for aseptic processing is an unacceptable practice. It is a direct risk to product sterility.

 

FDA warning letters on Glove Integrity:

  • Visible holes and flaking were observed in the gloves purporting to be sterile. In intact glove packages examined for the integrity of the gloves inside, our investigators found the gloves to have visible holes, flaking, cracking, and /or discoloration.
  • Gloves are worn during critical interventions such as making aseptic connections, clearing jams, clearing fallen vials, sterile primary and secondary closures, purging filling needles, adjusting equipment, and changing environmental monitoring plates. Because of gloves are worn during these critical interventions, using non-integral gloves for aseptic processing is an unacceptable practice. It is a direct risk to product sterility.

Conclusion:

The purpose of gloves in pharmaceutical is to avoid contamination of the product and to protect the patients’ health. Apart from the costs associated with high batch failure rates, contamination by biological agents of parenteral drugs can have serious consequences for patients. Hence, it is high importance to take maximum care while handling gloves in manufacturing activities of drug products. The failure in glove integrity is deemed to be GMP violations and resulting in drug products contamination.

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