Products Approved by the Ministry of Health

office [at] cygnuspharma.com

Products approved by the Ministry of Health

office [at] cygnuspharma.com

RELIABLE AND
EFFICIENT PRODUCTS
IN THE FIELD OF HYGIENE

Carried out in cooperation with experts from top research centers: Pasteur Institute Greece, QACS Lab, INCDMM, SGS as well as Prestigious Universities in Romania

Sanitizer Gel 120ml
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Sanitizer Gel 12x1L
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Sanitizer for Surfaces 750ml
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Sanitizer 53x3ml
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Sanitizer 3ml
Vezi Produsul

About Us

A WHITE SWAN PETROLEUM DIVISION

Since 2015, the laboratories WSP-CYGNUS Pharma support through research and development activities professionals from various sectors of activity related to the chemical and pharmaceutical industry with innovative products and technologies.

We decided to offer our support to medical professionals by launching the CYGNUS line of disinfectant products. Our continuous investment in research allows us to develop reliable and efficient products that fully meet the special requirements of hygiene and public health professionals.

The research program continues through the development of new formulations of products for the medical field, including OTC medicinal products. These are carried out in cooperation with experts from top research centers: Pasteur Institute Greece, QACS Lab, INCDMM “Cantacuzino”, SGS as well as prestigious universities in Romania .

The products for hand and surface disinfection made by our company are the result of applied research of two branches of the pharmaceutical industry ( pharmacological chemistry and cosmetology ). The raw materials used in the manufacturing processes are carefully selected and supplied by top companies in the pharmaceutical industry. The production stages are constantly monitored by the process engineers, the products being tested in the own physico-chemical analysis laboratory at each stage of the formulation.

The production unit is complex, fully automated, equipped with state-of-the-art measurement, homogenization and dosing systems, the entire production process being managed by a program specially designed for our company's standards.

The Quality Control Department ensures the conformity of the products delivered to the customer in all 5 stages from the moment of packaging production to the moment of delivery of the finished products.

The CYGNUS range of disinfectants is a unique premium product concept, which is a first for the Romanian pharmaceutical industry.       

Hand Sanitizer

120ml

With a compact packaging, used for the first time in Romania, CYGNUS HD - 120 ml is the ideal choice when you need a refresh and total protection against harmful microorganisms (viruses, bacteria and fungi). In addition to the broad spectrum of biocidal action, CYGNUS HD is dermatologically tested and due to the cosmetic ingredients used in the manufacturing processes leaves the skin soft and velvety regardless of the number of uses.

Cygnus HD 120ml
Cygnus HD 120ml
Cutie 36x120ml
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Cygnus HD 1L
Cygnus HD 1L Box
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Hand Sanitizer

CYGNUS HD

1L

Specially designed in HDPE packaging for intensive use in healthcare facilities, public institutions, educational institutions or in the industrial field, CYGNUS HD - 1L is the ideal choice due to the shape of the container and the robust dosing pump that precisely dispenses the amount of product needed for hand disinfection. according to the instructions for use in a single press.

Hand Sanitizer

CYGNUS HD

1L EcoPack

Specially designed in HDPE packaging for intensive use in healthcare facilities, public institutions, educational institutions or in the industrial field, CYGNUS HD - 1L is the ideal choice due to the shape of the container and the robust dosing pump that precisely dispenses the amount of product needed for hand disinfection. according to the instructions for use in a single press.

Cygnus HD 1L
Cygnus HD 1L
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Hand Sanitizer

CYGNUS HD

5L

Specially designed in HDPE packaging for intensive use in healthcare facilities, public institutions, educational institutions or in the industrial field, CYGNUS HD - 5L is the ideal choice for users who want to make storage spaces more efficient or use their own dispensers.

Cygnus HD 5L
Cygnus FD 750ml
Cygnus FD 750ml
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Surfaces Disinfectant

CYGNUS FD

750ml

Once on a certain surface, the mission of harmful microorganisms is to multiply in order to stay alive. The speed with which this process happens is surprising, and their lifespan on surfaces varies from case to case. CYGNUS FD is ideal for the medical, industrial, business environment, public institutions or why not, even for your own home being necessary only a few "fluff" for the complete destruction of viruses, bacteria or fungi. It is packaged in an HDPE container with an innovative design, equipped with a powerful sprayer for uniform coverage of contaminated surfaces. Protects surfaces and does not require rinsing. Completely cleans and degreases surfaces.

Surfaces Disinfectant

CYGNUS FD

5L

Once on a certain surface, the mission of harmful microorganisms is to multiply in order to stay alive. The speed with which this process happens is surprising, and their lifespan on surfaces varies from case to case. CYGNUS FD is ideal for the medical, industrial, business environment, public institutions or why not, even for your own home being necessary only a few "fluff" for the complete destruction of viruses, bacteria or fungi. It is packaged in an HDPE container with an innovative design, equipped with a powerful sprayer for uniform coverage of contaminated surfaces. Protects surfaces and does not require rinsing. Completely cleans and degreases surfaces.

Cygnus FD 5L

Hand sanitizer

CYGNUS HD

3ml

CYGNUS HD - 3 ml meets the needs of all customers, which is why the product is dosed and designed in such a way as to be perfectly adaptable to any situation. The disinfectant gel envelope is the most handy help when you need a quick hand disinfection at home, in recreational activities, shopping, but also in an organized setting, in various fields such as: educational, institutional, industrial, HORECA, etc. A great advantage of this product is that the sachets can be safely distributed to both your own team and customers, further increasing the safety of all.

Cygnus HD 3ml
Cygnus HD 53 x 3ml
Cygnus HD 3ml
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Products tested in accordance with the latest international standards.

The products are tested in our own physico-chemical analysis laboratory at each stage of the formulation.

Quantitative testing of the suspension to evaluate the virucidal activity of biocides in medical and domestic environments. It is the latest version of this test and involves the mandatory testing of virucidal activity on 3 strains of viruses, which have demonstrated the highest resistance to biocides, namely:

  1. Polyovirus type 1
  2. Adenovirus type 5
  3. Murine Norovirus

In the context of the pandemic, the latest version of the test also includes a separate verification of virucidal efficacy on the most resistant strain in the enveloped Coronavirus virus: Ankara Vaccinia.

Over several years the EN 14476 test has been used for individual testing of virucidal efficacy on various strains:

- Enterovirus (Coxsackievirus B4, B5)

- HIV

- Hepatitis A, B, C virus

- Herpes simplex virus

- Herpesvirus type 1 (pseudorabies)

- Cytomegalovirus

- Parvovirus

- Influenza A virus H1N1 sma

For this reason, the latest version of the test, EN 14476: 2014 + A2: 2019 + Ankara Vaccine, is a benchmark for demonstrating the effectiveness of virucides on any known virus.

Main areas of biocides tested:

  1. Hand disinfection by rubbing for 30 sec in domestic or public institutions and 120 sec in in-hospital environment (including surgery), at an average temperature of 20 ° C
  2. Disinfection of medical instruments: for one hour at an average temperature of 40 ° C.
  3. Disinfection of surfaces: between 5 minutes and one hour, depending on the cleaning or dirt conditions, at an average temperature of 30 ° C
  4. Disinfection of textile materials: at temperatures between 30 ° C - 70 ° C, maximum 20 min.

This test specifies a test method and the minimum requirements for mycobactericide (or tuberculocide), the activity of chemical disinfectants forming a homogeneous preparation, physically stable when diluted.
with hard water - or in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80% or less because a certain dilution is always produced by the addition of tested organisms and interfering substance.

Quantitative suspension testing for the evaluation of bactericidal activity in the domestic environment, food industry, public institutions and any other industrial environment (phase 2, stage 1).

The test is performed on the following bacteria:

  1. Pseudomonas aeruginosa
  2. Escherichia Coli
  3. Staphylococcus Aureus
  4. Enterococccus hirae (and / or Enterococcus faecium for temperatures ≥40 ° C)

 

It is also shown to be effective on Salmonella typhimurium, Lactobacillus brevis and Enterobacter cloacae, Pneumoniae, Clostridium difficile, Bordetella bronchiseptica, Aggregabacter actinomycetemcomitans, Campylobacter jejuni, Brucella canis, Enterococcus faecalis, Legionella pneumophilia, Sal cholerae sa

 

The test is effective for 1min-60min, at a temperature between 4 ° C-60 ° C, in conditions of cleanliness or dirt.

Quantitative testing of the suspension for the evaluation of fungicidal and levuricidal activity in the domestic environment, food industry, public and industrial institutions (phase 2, stage 1). Mandatory testing on: 1. Candida albicans 2. Aspergillus brasiliensis Optional: Saccharomyces cerevisiae. The test is performed in conditions of cleanliness or dirt at 20 ° C, for 15 min.

Quantitative suspension testing to evaluate the mycobactericidal efficacy of biocides in the in-hospital environment (including for disinfection of instruments), (phase 2, stage 1) Also valid for domestic and public institutions.

Mandatory testing on:

  1. Mycobacterium avium
  2. Mycobacterium terrae

The test is performed at 20 ° C for 60 min.

Quantitative suspension testing for the evaluation of bactericidal activity in the medical environment, food industry, public institutions and any other industrial environment (phase 2, stage 1).

The test is performed on the following bacteria:

  1. Pseudomonas aeruginosa
  2. Escherichia Coli K12
  3. Staphylococcus Aureus
  4. Enterococccus faecium

 

The test is at a temperature of 20 ° C, in conditions of cleanliness or dirt, for:

- 30sec-60sec for hand disinfection (including surgeon's hands)

- min 60 min for disinfection of instruments.

- maximum 5 min. for surfaces near patients.

- maximum 60 minutes for other in-hospital surfaces.

Quantitative testing of the suspension for the evaluation of fungicidal and levuricidal activity in the medical environment (phase 2, stage 1).

The test is performed on:

  1. Candida Albicans
  2. Aspergillus brasiliensis

 

The test is at a temperature of 20 ° C, in conditions of cleanliness or dirt, for:

- 30sec-60sec for hand disinfection

-1min-5min for disinfecting the surgeon's hands

- min 60 min for disinfection of instruments.

- maximum 5 min. for surfaces near patients.

- maximum 60 minutes for other in-hospital surfaces.

Testing the effectiveness of biocides for disinfecting surgeons' hands (phase 2, stage 2)

It is also valid for evaluating the efficiency of hand disinfection in any other conditions.

Testing takes place in several important stages:

  1. Careful washing of the surgeon's hands to remove mechanical particles and certain elements of pathogenic microflora. Take laboratory samples from the skin immediately after washing.
  2. Hand disinfection with the biocide proposed for testing. Use at least 4 ml of product, which is applied by rubbing for at least 60 sec. Larger amounts of biocide can be used repeatedly, respecting a hand rubbing time of at least 60 sec, up to 5 min.

Laboratory samples are taken again immediately.

  1. After 3 minutes, laboratory samples are taken again from the disinfected hands, without the surgeon touching anything during this time.

Repeated testing allows the determination of the mandatory remaining period of 3 min.

The results of the biocide test are evaluated against the efficacy of a 60% Propanol-1 ethanol solution. The testing is performed in parallel with a group of about 20 people: half will use the tested biocide, and the other half - the standard solution. The efficiency of the tested biocide must not be lower than that of the standard solution both immediately after application and after 3 min.

The test can be repeated in the same person after a period of at least one week to allow the restoration of normal skin microflora.

Test to evaluate the effectiveness of hand disinfection by rubbing, without prior hand washing (phase 2, stage 2). The test is valid for both medical and domestic environment, public institutions, its food industry

The test takes place on a group of about 20 young people, without hand injuries, with cut nails.

Half of the group will use the biocide under test, and the other half will use a standard solution: 60% 2-Propanol.

The hands of the tested persons will be infected with a suspension of Escherichia coli K12.

The standard solution will be used twice consecutively, 3 ml each, for 30 sec.

The biocidal product to be tested shall be used in similar quantities and times, or according to the manufacturer's instructions, but not exceeding the application time of 60 sec.

For the positive evaluation of the tested biocide, its efficiency should be better or equal to that of the standard sample.

Test for the evaluation of the irritating properties of the biocide on the Epidermis (upper layer of the skin) in vitro.

The test is performed by applying a quantity of biocide on RhE (reconstructed human epidermis) up to 60sec.

Cell viability is then determined using an ELIS photometer.

The evaluation of the irritating properties of the biocide is determined by the degree of viability of the cells tested.

Quantitative testing of the suspension to evaluate the virucidal activity of biocides in medical and domestic environments. It is the latest version of this test and involves the mandatory testing of virucidal activity on 3 strains of viruses, which have demonstrated the highest resistance to biocides, namely:

  1. Polyovirus type 1
  2. Adenovirus type 5
  3. Murine Norovirus

In the context of the pandemic, the latest version of the test also includes a separate verification of virucidal efficacy on the most resistant strain in the enveloped Coronavirus virus: Ankara Vaccinia.

Over several years the EN 14476 test has been used for individual testing of virucidal efficacy on various strains:

- Enterovirus (Coxsackievirus B4, B5)

- HIV

- Hepatitis A, B, C virus

- Herpes simplex virus

- Herpesvirus type 1 (pseudorabies)

- Cytomegalovirus

- Parvovirus

- Influenza A virus H1N1 sma

For this reason, the latest version of the test, EN 14476: 2014 + A2: 2019 + Ankara Vaccine, is a benchmark for demonstrating the effectiveness of virucides on any known virus.

Main areas of biocides tested:

  1. Hand disinfection by rubbing for 30 sec in domestic or public institutions and 120 sec in in-hospital environment (including surgery), at an average temperature of 20 ° C
  2. Disinfection of medical instruments: for one hour at an average temperature of 40 ° C.
  3. Disinfection of surfaces: between 5 minutes and one hour, depending on the cleaning or dirt conditions, at an average temperature of 30 ° C
  4. Disinfection of textile materials: at temperatures between 30 ° C - 70 ° C, maximum 20 min.

This test specifies a test method and the minimum requirements for mycobactericide (or tuberculocide), the activity of chemical disinfectants forming a homogeneous preparation, physically stable when diluted.
with hard water - or in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80% or less because a certain dilution is always produced by the addition of tested organisms and interfering substance.

Quantitative suspension testing for the evaluation of bactericidal activity in the domestic environment, food industry, public institutions and any other industrial environment (phase 2, stage 1).

The test is performed on the following bacteria:

  1. Pseudomonas aeruginosa
  2. Escherichia Coli
  3. Staphylococcus Aureus
  4. Enterococccus hirae (and / or Enterococcus faecium for temperatures ≥40 ° C)

It is also shown to be effective on Salmonella typhimurium, Lactobacillus brevis and Enterobacter cloacae, Pneumoniae, Clostridium difficile, Bordetella bronchiseptica, Aggregabacter actinomycetemcomitans, Campylobacter jejuni, Brucella canis, Enterococcus faecalis, Legionella pneumophilia, Sal cholerae sa

The test is effective for 1min-60min, at a temperature between 4 ° C-60 ° C, in conditions of cleanliness or dirt.

Quantitative testing of the suspension for the evaluation of fungicidal and levuricidal activity in the domestic environment, food industry, public and industrial institutions (phase 2, stage 1). Mandatory testing on: 1. Candida albicans 2. Aspergillus brasiliensis Optional: Saccharomyces cerevisiae. The test is performed in conditions of cleanliness or dirt at 20 ° C, for 15 min.

Quantitative suspension testing to evaluate the mycobactericidal efficacy of biocides in the in-hospital environment (including for disinfection of instruments), (phase 2, stage 1) Also valid for domestic and public institutions.

Mandatory testing on:

  1. Mycobacterium avium
  2. Mycobacterium terrae

The test is performed at 20 ° C for 60 min.

Quantitative suspension testing for the evaluation of bactericidal activity in the medical environment, food industry, public institutions and any other industrial environment (phase 2, stage 1).

The test is performed on the following bacteria:

  1. Pseudomonas aeruginosa
  2. Escherichia Coli K12
  3. Staphylococcus Aureus
  4. Enterococccus faecium

 

The test is at a temperature of 20 ° C, in conditions of cleanliness or dirt, for:

- 30sec-60sec for hand disinfection (including surgeon's hands)

- min 60 min for disinfection of instruments.

- maximum 5 min. for surfaces near patients.

- maximum 60 minutes for other in-hospital surfaces.

Quantitative testing of the suspension for the evaluation of fungicidal and levuricidal activity in the medical environment (phase 2, stage 1).

The test is performed on:

  1. Candida Albicans
  2. Aspergillus brasiliensis

 

The test is at a temperature of 20 ° C, in conditions of cleanliness or dirt, for:

- 30sec-60sec for hand disinfection

-1min-5min for disinfecting the surgeon's hands

- min 60 min for disinfection of instruments.

- maximum 5 min. for surfaces near patients.

- maximum 60 minutes for other in-hospital surfaces.

Testing the effectiveness of biocides for disinfecting surgeons' hands (phase 2, stage 2)

It is also valid for evaluating the efficiency of hand disinfection in any other conditions.

Testing takes place in several important stages:

  1. Careful washing of the surgeon's hands to remove mechanical particles and certain elements of pathogenic microflora. Take laboratory samples from the skin immediately after washing.
  2. Hand disinfection with the biocide proposed for testing. Use at least 4 ml of product, which is applied by rubbing for at least 60 sec. Larger amounts of biocide can be used repeatedly, respecting a hand rubbing time of at least 60 sec, up to 5 min.

Laboratory samples are taken again immediately.

  1. After 3 minutes, laboratory samples are taken again from the disinfected hands, without the surgeon touching anything during this time.

Repeated testing allows the determination of the mandatory remaining period of 3 min.

The results of the biocide test are evaluated against the efficacy of a 60% Propanol-1 ethanol solution. The testing is performed in parallel with a group of about 20 people: half will use the tested biocide, and the other half - the standard solution. The efficiency of the tested biocide must not be lower than that of the standard solution both immediately after application and after 3 min.

The test can be repeated in the same person after a period of at least one week to allow the restoration of normal skin microflora.

Test to evaluate the effectiveness of hand disinfection by rubbing, without prior hand washing (phase 2, stage 2). The test is valid for both medical and domestic environment, public institutions, its food industry

The test takes place on a group of about 20 young people, without hand injuries, with cut nails.

Half of the group will use the biocide under test, and the other half will use a standard solution: 60% 2-Propanol.

The hands of the tested persons will be infected with a suspension of Escherichia coli K12.

The standard solution will be used twice consecutively, 3 ml each, for 30 sec.

The biocidal product to be tested shall be used in similar quantities and times, or according to the manufacturer's instructions, but not exceeding the application time of 60 sec.

For the positive evaluation of the tested biocide, its efficiency should be better or equal to that of the standard sample.

Test for the evaluation of the irritating properties of the biocide on the Epidermis (upper layer of the skin) in vitro.

The test is performed by applying a quantity of biocide on RhE (reconstructed human epidermis) up to 60sec.

Cell viability is then determined using an ELIS photometer.

The evaluation of the irritating properties of the biocide is determined by the degree of viability of the cells tested.

“We use raw materials carefully selected and supplied by top companies in the pharmaceutical industry, a production line constantly monitored by process engineers, the products being tested in our own physico-chemical analysis laboratory at each stage of development.”

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