Secure commitment from all staff in a process of continual improvement of products and services offered to customers, and the processes that result in these products and services.
We are pleased to present our website, where we hope you find all the information you may need related to the products and services EFELAB SRL provides.
EFELAB SRL was a member company of MEDYLAB Group, a holding formerly composed by many Argentinean firms doing business in the following areas: Medical Equipment, Laboratory, Diagnosis Reagents, Disposable Items, Surgical Equipment, X-Ray Equipment.
The main purpose of the companies that formed MEDYLAB Group was to achieve new markets by enforcing the quality and variety of its products. Corporate actions were grounded on a jointly-created sales force, thus minimizing costs and maximizing results.
Even though the group is no longer operating worldwide the exporting vocational spirit and the vast experience achieved during those years allows us to offer proffesional advice and support and high-quality and reliable sterilizations supplies among other solutions for CSSD.
Our seriousness and trayectory has been recognised several times by National Organizations. In 2005 and 2007 we were awarded by ExportAr Fundation and we obtained the first prize for “Class & Service to Export Process” and also Best Argentinian Exporting Holding in 2007 and 2008. These recognitions to our labour fill us with pride and give us more energy to keep up working in the same direction. Our goal is to privide high quality products at competitive prices focusing on the customer`s satisfaction.
CERTIFICATES AND DOCUMENTS
EFELAB SRL does have free sales certificates for many of its products issued by the ANMAT (Argentinean Drugs and Medical Technology Administration). This is one of our goals into our Quality Management System. As regards products manufacturing our company has implemented and certiffied ISO 13485-2016 and GMP quality standerds.
WHAT IS STERILIZATION?
Sterilization is a term referring to any process that eliminates (removes) or kills all forms of life.
including transmissible agents (such as fungi, bacteria, viruses, spore forms, etc.) present on a surface
contained in a fluid, in medication, or in a compound such as biological culture media.The term has evolved to include the disabling or destruction of infectious proteins such as Prions related to Transmissible Spongiform Encephalopathies
WHAT IS ETHYLENE OXIDE (ETO)?
The Ethylene Oxide (ETO) is a colorless and odorless gas discovered by Wurz in 1859. Its antibacterial action was discovered in 1928. Since 1949, this gas has been introduced as sterilizing agent in medicine. ETO’s sterilizing capability depends of its toxic effects over living cells. In chemical terms, it behaves as an alkylating agent whose main property consists in replacing an hydrogen atom in the molecular proteins of the microorganism for an hydroethyl and interfering with its metabolism, affecting normal physiological activity and causing the death of the microorganisms. Chemical Formula: C2H4O, Molecular Weight: 44.05
It is a highly reactive susbstance:
- It reacts in presence of water to form ethylene glycol.
- It reacts in presence of chloride ions to form ethylene chlorhydrin.
- It has alkylating properties in combination with other chemical groups such as sulphydric, amino, carbonyl, etc.
- Solubility in Water: Very soluble
- Gas Odor: Perceptible over 500 – 700 ppm (according to the author)
- Solubility in Organic Solvents: Soluble in almost all
- Steam Pressure 1095 mm Hg at 20 º C Steam Density: 1.52
- Boiling Point: 10,4 º C at 760 mmHg
- Vaporization Heat: 0,1 Kcal/mol at 1 atm.
- Freezing Point: -112,6 º C
- Gas Color: Colorless, Ignition Temperature: 429 º C
- Flash point: – 20 º C
WHICH ELEMENTS MAY BE STERILIZED BY ETO AND WHICH MUST NOT?
The following items may be sterilized (and its utilization is officially indicated): all thermal sensitive plastic items: gloves, rubber, probes, tubes, catheters, prostheses, implants, optical instruments, pacemakers, assistance devices, electric materials, papers, among others The following must not be ETO-sterilized: aqueous solutions, greases, textiles, oils and any other element(s) that can be sterilized by means of other methods such as Heater and Autoclave (saturated steam. Moreover, elements likely to produce sparking, such as batteries, etc., must never be ETO-sterilized.
WHAT ARE ETO STERILIZATION’S ADVANTAGES?
ETO sterilization has the following advantages:
- High bactericide, viricidal and fungicide effectiveness. It destroy bacteria in their vegetative and sporulative form, fungi, rickettists and viruses.
- Outstanding spread over all types of materials. That’s why, it penetrates into and spreads throughout all areas of the elements to be sterilized.
- It does not deteriorate metallic instruments.
- It does not alter the chemical composition of sterilized elements.
- It allows to sterilize at low temperature conditions. Specially indicated for thermal sensitive biomedical materials because it does not deform or destroy the elements after being processed.
- It may be neutralized with water.
WHAT ARE ETO STERILIZATION’S DISADVANTAGES?
This sterilization method results in a slow process since a variable period enabling to ventilate sterilized material must be added to sterilization time itself. Hence, subsequent ventilation period vary according to the type of material (e.g. metal, glass, plastic, etc.) and the utilization intended (both extra-corporeal or external utilization and intra-corporeal or internal utilization).
The following ventilation times are often recommended for external utilization materials:
|MATERIAL||Ventilation Days (stored in polyethylene packaging)|
|External clothes||1 Day|
|Latex, Buna (synthetic rubber) gloves, etc.||1 Day|
The following ventilation times are often recommended for internal utilization materials:
|MATERIAL||Ventilation Days (stored in polyethylene packaging)|
|PVC Tubes and Probes||10 Days|
|Rubber Tubes and Probes||7 Days|
|Polyethylene Tubes and Probes||3 Days|
|Syringes and Catheters||2 Days|
Above mentioned times refer to polyethylene packaging. If paper- or pouch (laminated paper)-type containers are used, ventilation periods reduce in about 30%. Once the material to be sterilized has been processed, ventilation in full compliance of at least times set forth must be accomplished. Increasing above periods is recommended, since when ventilation times become higher, ETO remnants tend to zero value
Misuse adversely affects your health.
HOW IS ETO USED?
Ethylene Oxide may be used either solely or in combination with other substance mixtures. Moreover, it is basically
- a) marketed in two forms: (a) in small doses, being supplied as small glass ampoules and disposable metallic cartridges (used in sterilization units).
- b) in-bulk packaged in cylinders or tanks (used in industrial type sterilizing chambers).
Pursuant to their technology, sterilization units using ETO may make use of it in two ways:
- 1. 1. Utilizing Ethylene Oxide with Other Substance Mixtures. Carbon Dioxide and Freon are the most frequently used compounds to make the mixtures. On the one hand, however, during these last years, this way of utilization is gradually becoming less popular mainly because, when mixed with Carbon Dioxide, ETO needs high pressures thus hindering its handling and because freon is hardly utilized due to the ecological damage it cases (as propellant, freon has been prohibited under Montreal Agreement (1985). On the other hand, using these mixtures, necessarily causes the sterilization unit to operate with positive pressures and, if leakage occurs, ETO leaks to the external side of the chamber may possibly happen.
- 2. 2. Utilizing Ethylene Oxide Solely: Sterilization units work with negative pressures by means of vacuum pumps. ETO is then introduced into the chamber. Under these circumstances, it is highly unlikely to note any leaks from the unit outwards as, during sterilizing agent ETO-material contact period , the sterilization unit preserves the vacuum condition. At the final stage, these units vacuum once again, by ventilating and removing sterilizing agent ETO from the chamber and sending to an enclosure containing water. This step is performed to convert ETO into Ethylene Glycol, a neutral agent.
Utilizing Ethylene Oxide in glass ampoules has become a hand-operated sterilization method. Although safe and reliable EFELAB mini-sterilizers may be also utilized.
This system consists in using glass ampoules placed within a containment bag. It is a very useful and user-friendly unit. It may be used wherever and whenever. No special connections are needed. Ideal for emergency and/or catastrophic situation.
WHAT FACTORS SHOULD YOU BEAR IN MIND TO PERFORM A PROPER STERILIZATION?
When performing proper sterilization, the following factors must be taken into account: GAS CONCENTRATION, EXPOSURE TIME AND TEMPERATURE, RELATIVE HUMIDITY, MATERIAL VENTILATION.
- Gas Concentration: A concentration ranging between 450 and 525 mgr / ETO liter is recommended. Nevertheless, it can be stated that concentration is inversely proportional to exposure time, that is, the lower concentration is made, the higher exposure time will be noted. It is necessary to keep the concentration stable throughout the whole contact period between the material to be sterilized and ETO.
- Exposure Time: It mainly depends on gas concentration, temperature used and contamination degree. Exposure time must not be lower than 7 hours for highly contaminated elements. Features like packaging penetration time or gas spread throughout the material to be sterilized must be considered for providing extra time as safety range.
- Exposure Temperature: This is one of the variables considerably affecting the sterilization process. Temperature reduction needs contact period increase for assuring process effectiveness. Operating temperatures range between 25º and 60º C., although the recommended ones are situated between 45º and 50º C.
- Relative Humidity: Best results are obtained with a relative humidity ranging between 30% and 60%. Avid extremely dry environments., although it can be stated that room humidity prevailing at working site is sufficient. An excessive amount of water steam may combine with ETO within chamber location, thus resulting in ethylene glycol formation and, consequently, reducing gas concentration.
- Degassing or Aeration of the Material: Once sterilization cycle is completed, it is necessary to have a period of time for eliminating residual gas incorporated to the already sterilized materials. Aeration time may vary from a couple of hours up to several days according to sterilized material’s nature.
WHAT PRECAUTIONS SHOULD BE TAKEN WHEN USING AND HANDLING ETO?
Ethylene Oxide is toxic and, therefore, flammable:
- It should be reminded that ETO-made sterilization is an alternative method. Therefore, please limit the utilization of this gas to those cases where no other safer alternative methods are available.
- Concentrate the locations where ETO will be used. Assure permanent air renovation in the sterilization area through the use of forced air extractions.
- Evaluate and choose qualified sterilization units. Handle them properly. Perform their maintenance periodically and preventively.
- Perform ETO storing and transportation regulations
- Always avoid every contact between ETO and any ignition source (sparking, flame or fire) at working environment, transportation or storage facilities.
- Have education and training programs specially addressed to sterilization area staff
- Prepare a plan for emergencies and catastrophic cases.
- Should, for any reason, liquid ethylene contact operator, the area involved must be thoroughly washed with plenty amounts of cold water.
- If any respiration disturbance is observed, the individual must be given oxygen until physician’s arrival.
- If ETO vapors are inhaled, go to outdoors immediately.
In any case, following first aid measures, call up a physician urgently.
Our company has successfully passed the GMP -Good Manufacturing Practices- and ISO 13485- specific quality norm for medical devices- certification audit.
The audit was conducted by the Argentinian Institute for Standardization and Certification (IRAM) under the scope “Manufacturing and sale of ethylene oxide cartridges and ampoules, sterilization indicator inks, chemical indicators for sterilization in strips, tapes and adhesive labels and sterilization packaging”.
This certification is accredited by OAA (Argentine Accreditation Agency) and IQNet (the largest international network of certification bodies worldwide).
Achieving these certifications demonstrates that the organization complies with internationally recognized standards and their application involves systematizing processes and continuous improvement, especially oriented to customer satisfaction and to achieving safe and effective products.
We want to share the satisfaction of this achievement, result of the work of our staff in all areas, as it has been the target aim in order to be closer to our customers by providing quality products. Thus it reaffirms our commitment to quality since we are now the first and only company in the Argentinean market which has achieved ISO 13485 certification for the manufacturing of ethylene oxide cartridges and ampoules and sterilization packaging.
EFELAB privileges customer satisfaction, for it has been proposed that products and services provided by the company meet the expectations and requirements of its clients, in that direction is oriented quality management assuming the next principles
Striving for excellence on an ongoing basis by identifying opportunities for improvement in both internal management and in product development and customer relations.
Maximize productivity and optimize resources. Continuously improving the quality and safety of its products and business management.
Develop new products based on customer needs.
The human factor is an essential component in the implementation of quality management, this can only be achieved through communication, involvement, training and teamwork at all levels of the company.
That meets the requirements of GMP, ISO 13485: 2016, ANMAT Provisions 3265/13, 3266/13, 2318/02, 2319/04, 6052/13 and amendments, Directive MDD 93/42, QSR-FDA and national and regional regulatory frameworks applicable in the countries in which it is marketed.