CODEN (USA): IJCRGG, ISSN: 0974-4290, ISSN(Online):2455-9555 Vol.11 No.06, pp 90-98, 2018
Abstract : This study intended to demonstrate the importance of having a standard quality of medical gloves and the requirement needed to meet the standard specifications set by regulatory authorities such as ASTM, EN, and ISO etc. The recent regulatory citations and warning letters revealed that major pharmaceutical companies in India had serious noncompliance issues in handling gloves into their receipt, testing, storage and issuance to production use. The gloves were tested to check the quality is within the limit as per ISO 2859-1. The quality control test was carried out on sterile, non sterile and hypalon glove by following the ISO sampling procedure 2859-1 The tests includes visual examination test, water leak test for pinhole detection, physical dimension test, and pressure drop test for hypalon glove. The result of those test reveal that the gloves are meeting the standard requisites set by the different agency, hence the glove can be distributed and used in pharmaceutical clean room. Carrying out those tests will avail to avert the product from contamination, and transmission of disease between health care professional and the patient. The reason behind the study on clean room glove is to demonstrate the importance of utilizing standard quality of clean room gloves. The recent regulatory citations and warning letters revealed that major pharmaceutical companies in India had serious non-compliance issues in handling gloves into their testing, storage and issuance to production use. It was found the use of non sterile glove in sterile area was in violation to cGMP. Clean room glove is one of the main sources of product contamination and using clean room glove as the contamination control kit can avail to reduce the product contaminations. In this study, the quality control tests for clean room glove were carried out as according to ISO, ASTM and EN. Keywords : Clean room glove, Medical glove, Contamination.
Key materials which are used in support of manufacturing or which arecoming in contact with the products during manufacturing that may not become partof final product.
Direct quality impacting: Consumables which will have direct contact withproduct and directly affect the quality, purity, strength and safety of the final product.Examples are product filters, product contact tubing and process gases, polyethylene bags etc. Indirect quality impacting: Consumables which do not come into direct contact with the product and may affect the quality, purity, strength and safety of the product. Examples are gloves, garments, lubricants, wipes/mops, etc. Non-quality impacting: Consumables which will not affect the quality, purity, strength and safety of the product. Examples are engineering tools and housekeeping items etc.
Pharmaceutical gloves 1-2
The recent past regulatory citations and warning letters revealed that major pharmaceutical companies in India had serious non-compliance in handling gloves into their receipt, testing, storage and issuance to production use.
Importance of gloves quality
Gloves are used by medical professionals, such as doctors, surgeons, pharmacists and biochemists. All rely on medical gloves as an effective barrier against the transmission and spread of disease and blood
and fluid-borne infectious agents. These are important to prevent the wide verity if diseases to both the patient and health professional. This also helps to prevent the cross contaminations.
Note: Wearing gloves is not a substitute for proper hand washing and hygiene, but using them gives greater protection.
Classification of Gloves3-5
Classification according to FDA based on surgeon’s and patient examination gloves.
1. Surgeon glove:
These are future classified as follows:
2. Patient glove:
These are future classified as follows:
The selection of which glove to use is based on multiple factors, including type of procedure, need for chemical resistance, barrier effectiveness, fit, comfort and tactile sensitivity.
Table 1: Difference between examination gloves and surgical gloves
SlNo | Parameters | Examination gloves | Surgical gloves |
---|---|---|---|
1 | Hand size | Ambidextrous in design | Surgical gloves are designed hand specific |
2 | Sterility | Non sterile | Sterile |
3 | Physical Dimensions | Thinner and shorter length | Thicker and longer |
4 | Process | Non critical | Critical |
It is important to understand the application of consumables and criticality in usage of them in production and quality control aspects to define their pre-determined quality attributes. Though these consumables (Glove) are not a part of product composition, it is playing an important role in minimizing the contamination into the drug products. Hence, it is a right time to start the implementation of consumable management in pharmaceutical industry to meet product quality and safety requirements.
Table 2:Components of gloves
Name of Components | Functional property | Example |
---|---|---|
Antioxidant | To prevent the deterioration of rubber molecule | 4-and 5 Methyl mercapto-benzimidazole sterically hindered polymeric phenol |
Pigment | To differentiate by color | Titanium dioxide |
Activator | To catalyze the reaction. | Active zinc oxide |
Vulcanizing agent | A chemical process for converting natural rubber or related polymers into more durable materials via the addition of sulfur | Sulfur |
Accelerators | Increasing the speed of cross linking between polymer and sulfur | Diisopropylxanthaogen poly (4) sulphide, Zinc diethyl Dithocarbamate, Sodium dibutyldithiocarbamate |
Coagulant Agent | Uniform distribution of latex over the former | Calcium nitrate |
Former Cleaning agent | To remove the organic metal | Nitric acid Sodium hypochlorite |
Lubrication | To facilitate stripping (removing)the gloves from the molds at theend of the production line. | Silicon, Corn starch |
Anti-webbing agent | A Deformer or an Anti-foaming agent/Anti-webbing agent is a chemical additive that reduces and hinders the formation of foam in industrial process liquids | Polymethylsiloxane |
Thickener | A substance added to a liquid to make it firmer | Hydroxyethyl cellulose |
Stabilizers | A thing used to keep something steady or stable) | Potassium caprylate, Potassium laurate, Potassium hydroxide, Ammonia. |
Performance requirements
Gloves shall be sampled and inspected in accordance with ISO 2859-1. Gloveshall meet the following
referee performance requirements
Comply with requirement for sterility when tested in accordance sterility testmethod
Be free from holes
Have consistent physical dimensions
Have acceptable physical property characteristics
Have a powder residue limit of 2.0 mg
Have a recommended aqueous soluble protein content limit of 200 μg/dm2
Have a recommended maximum powder limit of 15mg/dm2
Table 3: Routine release criteria of gloves How to don/doff the gloves Sampling6-8
SL No | Test | Specification limits |
1 | Description | Off-white to pale yellow color cuff beaded,powder free rubber gloves. |
2 | Visual examination (Pouch) | Should be free from extraneous matter,sealing defects, damage and labeled as“Sterile” |
3 | Visual examination (Gloves) | Should meet AQL 1.5, G2 ISO 2859 |
4 | Length | Not less than 480 mm. |
5 | Width | Between 102 mm to 114 mm |
6 | Thickness (Cuff) | Not less than 0.14 mm |
7 | Water leaktest (for pin holes) | Should meet AQL 1.5, G2 ISO 2859 |
8 | Tensile strength-before ageing | >= 24 MPa Not less than 24 MPa |
9 | Tensile strength-after Ageing | >= 18 MPa Not less than 18 MPa |
10 | Ultimate Elongation-before Ageing | >= 750 % less than Not less than 750 %ageing |
11 | Ultimate Elongation-after | >= 560 % Not less than 560 % |
12 | Force at break-before Ageing | >= 9 N Not less than 9 N |
13 | Force at break-after ageing | >= 9 N Not less than 9 N |
14 | Protein content | <= 50 μg Not more than 50 μ g/dm2 |
15 | Powder residue | <= 2 mg Not more than 2 mg/glove |
16 | Sterility | Must comply |
This sampling procedure has been followed while performing the quality control test for cleanroom gloves and the following sampling procedure (ISO 2859-1) are particularly for gloves only.
Sampling instruction
Selected 2000 non sterile and 1000 sterile glove packs and conducted sampling in accordance with the
sampling as given in sampling and inspection plan for gloves Note-Pack can be shipper or bags or container. Refer GRN for verifying number of packs received Randomly selected the packs and collected a quantity such that the total quantity was equal to the sample
to be collected from the pack Check the sample collected, visually for gross obvious defects by referring table and annexure and record
the details in observation sheet Record the observation in sampling observation sheet Additionally record the observed non-conforming items (AQL) level in sampling observation sheet
Test Procedure
A. Description
Sample glove was taken to the visual inspection table and checked each gloves for its appearance as described in specification and observation was recorded.
B. Visual examination
Sample glove was taken to the visual inspection table and checked each gloves for visual examination of physical defects such as rupture/cut/lumps/crack/beadlesscuff etc; as per inspection G1 AQL 1.5 (for non-sterile glove) and observation was recorded.
C. Length of the glove
Gloves were placed flat on an even surface and measured the length by measuring the distance from the middle finger tip of the glove to the cuff edge using measuring graduated rule and observation was recorded.
D. Width of the glove9
Gloves were placed flat on an even surface, folded the thumb portion of the glove and measured the width by measuring the distance between end of the thumb to the end of the small finger and observation was recorded.
E. Water Breakthrough Test or Leak Test
The water breakthrough test utilized water pressure to inflate the glove. Visual inspection of the glove was carried out to find the presence of pinhole, which can be indicated by droplets of water on the surface of the glove10. The test was carried out byfilling the glove with 1 litre of water and then it was hanged in order to observe for the leakage after2 minutes.
Advantage
Pinholes in fingertips are more easily recognized.
F. Pressure drop test
The pressure drop test measures the pressure decay as an indicator of a leaky glove11.
Procedure
Fixed the hypalon glove to the gauntlet and it was verified for any wrinkle on the glove port glove and closed the glove integrity testing cabinet door. The integrity tester was switched on and after the completion of inflation phase, stabilization phase was carried out for 420 sec. After the completion of stabilization phase, measurement phase was started. In this phase pressure decay per unit time of the glove was measured over the defined measurement time i.e. 360 sec. After the completion of test, result were displayed in the “Port status screen” and recorded.
Pressure Drop Test
Acceptance criteria : The pressure drop of gloves must NMT 150 pa at set pressure of 2000 pa and test time of 6 minutes.
Table 4: Set parameter for gloves integrity testing
Set parameters | Set value |
Start/Test pressure | 2000 pa |
Inflate time out | 180 sec |
Stabilization time out | 420 sec |
Pulse count | 25 Nos |
Test time or holding time | 360 sec |
Pressure decay limit | 150 pa |
G. Thickness of glove
Thickness of the gloves was expressed in millimetres using dial micrometre in three different locations such as finger, palm and cuff.
It is important to utilize standard quality of gloves and there should be congruous quality system regulation, sampling should be done as per ISO 2859-1 by inspectors of the quality control laboratory and performing those tests and meeting those tests acceptance limit will assure that clean room/medical gloves are safe to utilize.
This project work was carried out to understand the importance of clean room glove in pharmaceutical application and the mandatory tests which are needed to be performed as per regulatory agency. The results were found to be good and within acceptance limits. A summary of each test carried out for description, visual examination, length, width, water leak test or pinhole test and pressure drop test studies are as follows:
A. Description:
The description test has been performed to check whether description given by the manufacture is meeting with the recorded observation.It was found to be satisfactory for all the three gloves.
B. Visual examination:
The visual examination test has been performed to checkwhether it was free from extraneous matter and free fromrupture/cut/lumps/crack. It was found to be satisfactory for all the three gloves.
C. Length:
The test to measure the length of the clean room glove has beenperformed to check whether it was meeting with the manufacturer’s certificate of analysis. The length plays important role in controlling the contamination ofthe product, where longer length glove allows the sleeve to be tucked into theglove, thus eliminating contamination problem. It was found to be satisfactoryfor all the three gloves.
D. Width:
The test to measure the width of the clean room glove has beenperformed to check whether it was meeting with the manufacturer’s certificateof analysis. It was found to be satisfactory for all the three gloves.
E. Water leak test:
Water leak test has been performed to check the presence ofpinholes in the gloves through which the microbes can migrate which leads tocontamination of the product. It was found to be satisfactory for all the threegloves.
F. Pressure drop test:
Pressure drop test has been performed to hyplaon glove only, to detect the pinhole by using the pressure drop decay method. It wasfound to be satisfactory.Based on the test performed on cleanroom gloves, it was concluded that the cleanroom gloves met those specifications set by the agencies; therefore they weresafe to be utilized in pharmaceutical cleanroom, medical examiner, dental examiner,health care technicians and associated workers12.
1. Sivakumar V. Managing consumable materials in pharma sector,Pharmabiz, August 12, 2015.
2. Guidance for Industry and FDA Staff Medical Glove Guidance Manual-Google Search [Internet]. [Cited 2017 July 25].
3. Mylan Laboratories Limited 8/6/15 [Internet]. [Cited 2017 Aug 28].
4. Hospira Healthcare India Pvt. Ltd.5/28/13 [Internet]. [Cited 2017 Aug 28].
5. Agila Specialties Private Limited 9/9/13 [Internet]. [Cited 2017 Sep15].
6. Hazard associated with glove powder ansell care -Google Search [Internet]. [Cited 2017 Sep 25].
7. RPGMfgprocess.ppt [Internet]. [Cited 2017 Oct 28].
8. Angela Gessler, Alexandra Stark. How Risky Are Pinholes in Gloves? A Rational Appeal forthe Integrity of Gloves for Isolators -Google Search [Internet]. [cited 2017 Sep 25]
9. Selecting glove, cleanroom technology -Google Search [Internet]. [Cited 2017 Sep 25].
10. Standard specification of rubber surgical gloves ASTM D3577 -Google Search [Internet]. [Cited 2017 July 28].
11. Glove Use Information Leaflet -Google Search [Internet]. [Cited 2017 Oct 28].
12. AnsellPro.com Technical Center, FAQ [Internet]. [Cited 2017 July 29].
*****