Services Archive - Page 2 of 3

Clean rooms

Clean Rooms – As a leading microbiology company in Israel, which serves critical industries, such as pharmaceutical preparation, cell therapy, medical devices, and medical cannabis, we offer a complete solution for clean room monitoring and clean room disinfection. Our experienced GMP-trained team will come to sample your clean room according to the regulations and your needs, incubate and count the plates, and provide you with a GMP report. We also offer a full validation of clean rooms by our validation team from start to end, including documentation, validation execution, and microbial identification. These clean room validations include disinfectant efficacy tests of your disinfectants against your specific isolated microorganisms.

We also offer complimentary tests for clean room: Sterility test, Bacterial endotoxin test, Bacterial Identification, Ecology and Morphology.

Cleaning and disinfection – clean rooms
Monitoring solutions for clean rooms

Chemistry

ICP-MS:

We offer an element scanning technology with the highest matrix tolerance and unmatched interference removal that allows us to analyst a great verity of samples and deliver fast, accurate and consistently reproducible results even for trace metals. We are a certified laboratory and work under the stringent regulation of GMP, ISO 17025, ISO 9001 and IMCA.

Our laboratory is equipped with The Agilent 7900 ICP-MS, a flexible quadrupole mass spectrometry system that provides the industry’s lowest detection limits, widest dynamic range, and most effective helium collision mode:

Unprecedented matrix tolerance—Agilent’s 7900 ICP-MS has a robust plasma and optional Ultra High Matrix Introduction (UHMI) technology that enable you to routinely measure samples containing up to 25% total dissolved solids (TDS)—100 times higher than the traditional matrix limit for ICP-MS, and far beyond the capability of any other current system.

Widest dynamic range—the new orthogonal detector system (ODS) delivers up to 11 orders of magnitude dynamic range from sub-ppt to percent-level concentrations, enabling you to measure trace elements and majors in the same run.

Better trace level detection—novel interface design and optimized expansion-stage vacuum system increase ion transmission, providing >109cps/ppm sensitivity at <2% CeO, while the ODS provides increased gain and reduced background for improved signal to noise.

Faster analysis of transient signals—with 10,000 separate measurements per second, we provide a short integration times for accurate analysis of transient signals

For the pre-treatment of your samples, our laboratory is equipped with an UltraWAVE microwave, which is based on the SRC (Single Reaction Chamber technology) and compliance with the USP 232/233 Chapters, ICH Q3D Guidelines and FDA regulation 21 CFR part 11

SRC technology achieves extraordinary performance capabilities combining microwave heating with a high-pressure reactor which acts simultaneously as microwave cavity and vessel. With the UltraWAVE technology we can attend to every sample preparation need, we can pre-treat any sample imaginable: Pharmaceutical product, Cannabis, Plant base material, Inorganic solutions, Polymers, soils, alloy, food and more …

TOC (Total Organic Carbon) :

Total organic carbon (TOC) is the amount of carbon found in an organic compound and is often used as a non-specific indicator of water quality or cleanliness of pharmaceutical and manufacturing equipment.

Hy Laboratories is equipped with the new OI Analytica’s Aurora 1030W TOC Analyzer for the detection of total organic carbon (TOC) to provide you with the right solution for your TOC need. The system is fully automatic and using heated persulfate oxidation technology to detect TOC in a 0.5-30,000ppm range. The Aurora supports USEPA approved methods: USP <643> methods EU 22.44, 23 and complies with the GMP regulation. Hy Laboratories labs are certified GMP, ISRAC (ISO17025), ISO13485and ISO9001

In what areas TOC tests are routinely required?

Municipal Waste Water

Monitoring organic carbon of influent facilitates process controls for maximizing plant efficiency, while monitoring effluent is often a requirement for discharging into surface waters.

Industrial Waste Water

Industries which discharge liquid waste into a surface water body are required to monitor TOC.

Power Plants

Limiting potential sources of corrosive compounds can prevent costly damage to expensive equipment.

Pharmaceutical Manufacturers

Water is the most commonly used ingredient in drug production. Regulations limit the concentration of organic carbon to prevent harmful microorganisms from growing.

Electronics Manufacturers

Ultra-pure water is used in the manufacture of microprocessors and computer chips. As processors and circuits become smaller and smaller the water must be kept highly clean to prevent microscopic damage to these miniature circuits.

Cleaning validation

In the pharmaceutical industry, GMP production requires that the cleaning of drug manufacturing equipment/Medical device will be validated. Many different validation techniques can demonstrate that the manufacturing equipment is cleaned and essentially free from residual active drug substances and all cleaning agents.

TOC analysis can be adapted to any drug compound or cleaning agent that contains carbon. The method is sensitive to the ppb range and is less time consuming than HPLC or UV/Vis. USP TOC methods are standard for Water for Injection and Purified Water, and simple modifications of these methods can be used for cleaning validation.

Environmental Monitoring

Even in the most advanced and secured clean room environment, microbial contamination is unavoidable. Environmental monitoring review of microbial controlled environments such as clean rooms and Laminar air flow hoods, is required in order to assure control is being maintained.

Sampling methods rely on growth of microorganisms on media such as Soyabean Casein Digest Agar (TSA) and Sabouraud dextrose agar (SDA) which supports the growth of a wide range of bacteria, yeast, molds and fungi.

Hy Laboratories offer the service of our skilled and certified samplers. Our samplers will come to your facility and perform the entire sampling process. We provide the plates and an Active Air Sampler and all other needed equipment according to the costumers needs.
As well as routine sampling, a PQ validation of clean rooms is also offered including planning and advising, writing of protocol, performing the sampling and issuing a final PQ report.
After the sampling process our sampling team delivers all plates and information to the Laboratory for the incubation step. Incubation time and temperature varies between different growth media. At the end of the incubation period, colony forming units are being counted and reported. Following the incubation and count, an identification of bacterial growth may be provided

We also offer complimentary tests for Environmental: Clean room validation, Bacterial Identification, Ecology & Morphology, Disinfectant Efficacy

Cannabis testing

Medical Cannabis is a growing branch. Although it is not a drug it is under the regulation of the Israeli Health Department (Yakar). The microbiological testing we provide is based on pharmacopeial methods and in house methods developed for Medical Cannabis and is qualified by the Israeli Health Department and the Israel Laboratory Accreditation Authority (רשות להסמכת מעבדות).
Medical Cannabis Testing – We perform the test for Total Count and Yeast and molds and the test for absence of Specified Microorganisms (E.coli, Staph. aureus, Pseudomonas aeruginosa, Enterobacteriaceae, Salmonella Spp., Shigela Spp., Listeria Spp. and E.coli O157).
In Addition, we test a variety of samples from Cannabis inflorescences, Oils, extracts, APIs, and finished products.

Medical Cannabis Testing within 48 hours
We are specialized in medical cannabis testing and leading in rapid testing of those products. We are the first lab to offer medical cannabis microbial testing in 48 hours. We offer full microbial testing and metal analysis (certified by the MOH YAKAR).

We also offer a Complemeteray test for Cannabis testing: BID

Medical Cannabis & Phytopathology – More Services

Dialysis water

Monitoring dialysis water quality is crucial to avoid excesses of known or suspected harmful elements being carried in the water and transmitted to the patient. Therefore, it is very important for the dialysate to meet the norms and conditions specified by the health ministry. It is recommended that every dialysis system will be checked monthly and after replacement or treatment of any component of the system.

In our lab we perform several tests to assess the quality of the dialysate:

TVC (Total viable count) – Gives an estimate regarding the concentration of all microorganisms such as bacteria, yeast, and molds, Pseudomonas aeruginosa, Fecal coliforms.
BET – test the dialysate for the presence and quantification of endotoxins by performing BET (Bacterial Endotoxin Test) also known as LAL test.
ICP-MS – test the dialysate for harmful heavy metals presence.
*For microbial testing – all dialysis water samples are tested within 6 hours from sampling time.

We also offer a Complementary test for Dialysis Water: Bacterial Identification, Ecology, and Morphology .

Mycoplasma Testing

Mycoplasma is the smallest free-living, self-replicating organism, found mostly on the outer surface of the cell membrane and rely on their hosts for nutrients. Consequently, mycoplasma has adverse effects on the characteristics of a contaminated cell line including changes in growth, morphology, metabolism, synthesis of DNA, RNA and protein, the antigenicity of cell membranes, and more.

Mycoplasma frequently infects cell cultures and cell-derived biological products (e.g., vaccines and recombinant protein), but the contaminated matrix does not display any visible signs of contaminations (such as changes in turbidity, pH or cytology). Moreover, once found, mycoplasma contamination is difficult to eliminate since most routine antibiotics used in cell culture are ineffective against mycoplasma, and common filtrations techniques fail to remove mycoplasma due to their small size.
Most contaminations are caused by 8 species of mycoplasma and it is estimated that 5-35% of cell cultures in current use are infected by mycoplasma.
Therefore, testing for mycoplasma is a necessary quality control requirement to assure the safety of biotechnological products and related materials introduced during the manufacturing process.

As a leading service lab in Israel, we offer both microbial and molecular testing methods: mycoplasma culture method (28 days), nested PCR method (1-3 days) and the latest innovative Real-time PCR (8-24 hours).
While both the microbial and molecular methods have similar sensitivity (as required by the Pharmacopeia), the most essential differences between those methods are that the culture test detects only viable mycoplasma, whereas a PCR-based test detects both live or dead mycoplasma, but with fastest turnaround time.
Our standard operation procedure relies on USP<63> and EP<2.6.7> and GMP approved.

We offer complementary services and products for Mycoplasma Testing:
Cell Culture, Virology as well as Hy-Mycoplasma detection Kit

Disinfectant Efficacy

The purpose of this study is to determine the efficacy of the disinfectant reagents used for the sanitization of surfaces in controlled manufacturing facilities and performed according to USP <1072>.

The disinfectants efficacy is evaluated by the determination of survival rate of selected microorganisms spiked on coupons (such as PVC, stainless steel, glass etc.) or test tubes after being exposed to selected disinfectants for a pre-defined contact time.

The study can be performed with ATCC challenge microorganisms and with Sponsor environmental isolates (Wild Strains).

We also offer complimentary tests for disinfectants efficacy: Bacterial Identification

Cleaning & Disinfection

The manufacturing of reusable medical device must accompany detailed instructions on how to reprocess the device between patient uses in the hospitals. Cleaning of the device is a critical step in reprocessing of any device after it has been used on a patient. Failure to remove foreign material from the device can interfere with the effectiveness of subsequent disinfection and/or sterilization.

Residues of protein and TOC are being tested as part of Cleaning Validation, after performing a shortened cleaning procedure according to TIR30.

Log reduction of chosen microorganisms is being tested as part of Disinfection Validation, after performing a shortened disinfection procedure according to TIR12.

Bioburden

Materials and products that are to be sterilized should be examined to determine the level of bioburden (microbial load/count) in the article, prior to its final sterilization.

Monitoring of in-process bioburden of pharmaceutical components and products is an essential element of the overall contamination-control program for appropriate sterilization process control.

Bioburden monitoring should be designed for the recovery of a broad range of microorganisms that are likely to be present in the material being processed.

Pre-sterilization bioburden analysis should be conducted on samples that are representative of materials produced during routine preparation and processing

We also offer Complementary tests for Bioburden: Bacterial Identification, Ecology, and Morphology.

Sterility & LAL

Sterility test:

We are considered to be the most critical lab in Israel for sterility test product release. That specialty in sterility testing is due to our vast experience in adopting rapid methods for sterility such as BacT/ALERT and HB&L (see below) and by the fact that we test and support the critical companies in Israel from Cell therapy, Biopharma, and medical devices sectors.

Sterility testing is performed in order to establish the presence or absence of viable microorganisms and is carried out in a clean room, under aseptic conditions with highly trained technicians. Sterility test may be carried out using a Membrane Filtration technique or by Direct Inoculation of the culture medium with the product to be examined. Samples are incubated for 14 days in two types of media, which allow the detection of both aerobic and anaerobic microorganisms.

Hy Laboratories provides sterility tests in a Clean Room Class 1000 (ISO 6/Grade B) and under laminar airflow hood Class 100 (ISO 5/GradeA) conditions and serves the healthcare, pharmaceutical, medical device, and cell therapy industries.

We also offer complimentary tests for Sterility: Bacterial Identification, Ecology, Morphology, Clean Room Validation, Disinfectant Efficacy & BET (bacterial endotoxin test)

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BET (bacterial endotoxin test):

The bacterial endotoxin test, which is also known as LAL (Limulus Amebocyte Lysate), is an assay for the detection and quantification of bacterial endotoxins, a component of the cell walls of gram-negative bacteria, in drugs and biological products. Endotoxins are fever-inducing substances that can be harmful or fatal if administered to humans above certain concentrations.

The endotoxin test is derived from the fact that the horseshoe crab (Limulus Polyphemus) blood cells (amebocytes) react with bacterial endotoxins.

We provide services in 3 assays of the Bacterial endotoxin test:

· LAL Gel-Clot assay – a qualitative assay, considered as the “Gold Standard” in pharmacopeial monographs. The test involves mixing the sample and the LAL in a test tube and incubating, a positive result is indicated by the formation of a clot at the bottom of the tube. Suitable for all sample types.

· Kinetic Turbidimetric assay – a quantitative photometric assay, utilizing the clot formation as a parameter. The test involves mixing the sample and the LAL and placing the test tube for incubation inside a 96 tube spectrophotometer, which tracks the change in absorbance as the clot is forming compared to a standard curve. Suitable for drug, medical devices, and water testing.

· Kinetic Chromogenic assay – a quantitative colorimetric assay, quite similar to the turbidimetric assay. Tracks the change in color of the sample-LAL mix compared to a standard curve. suitable for medical devices and water testing.

*Both turbidimetric and chromogenic assays involve the use of a 21 CFR part 11 compliant software.