Largest Network of Labs

*Delhi NCR

Ahmedabad

Indore Kolkata

EXTRACTABLES &
Vishakhapatnam

Pune Bhimavaram

LEACHABLES
Hyderabad (HeadQuarters)
Bengaluru
Nellore

Cochin

SERVICE THROUGH UNCOMPROMISING COMMITMENT TO QUALITY!

Life Sciences Campus
Plot No.5, M N Park, Genome Valley, Shameerpet Medchal - 500101, Hyderabad, Telangana, India.

Tel: +91 40 6740 4040 |Email: bd@vimta.com |Website: www.vimta.com

/VimtaLL /vimta-labs-ltd www.vimta.com

 ABOUT VIMTA
LEGACY

Founded in 1984 with headquarters in Hyderabad, India, VIMTA LABS LTD., is a leading contract research 34 Years
and testing organization, providing bio/pharmaceutical companies an integrated scientific, technical
and regulatory expertise to support all stages of drug development and manufacturing process.
INFRA
VIMTA has been supporting many national and overseas companies for more than 3 decades, for their
third party testing, research and outsourcing needs. Along with the growth in pharma, food and other 350,000
manufacturing sectors, we have been able to grow and also expand our services to international markets. Sq ft. of lab space

GROWTH
Single bench to
Wold class laboratory
72%
Growth in5 years

PEOPLE

1100+ 700+
Scientists with wide,
strong team varied and strong technical expertise

QUALITY SYSTEMS
ISO 17075
cGMP, GLP, GCP ISO 15189
Compliant
ISO 9001

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 SERVICE PORTFOLIO QUALITY

VIMTA has successfully faced over 70 regulatory audits including 16 US FDA inspections and has an
excellent track record of delivering high quality services to its global customers.

PRECLINICAL CLINICAL
RESEARCH RESEARCH

cGMP
ANALYTICAL
ANALYTICAL
FOOD &WATER
SERVICES

BIOSIMILAR ENVIRONMENTAL
SERVICES ASSESSMENT

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 EXTRACTABLES AND LEACHABLES EXPERIENCE

Packaging materials & manufacturing components coming in contact with a drug product, active ingredient
or medical device are a potential source for chemical contamination, posing a risk to product safety and
quality. A detailed study of container closure system, manufacturing components and drug product is
becoming increasingly necessary to evaluate the impact of such interactions. Data
Pioneer in Over 500 submitted
Extractable and Leachable study is a critical regulatory requirement which requires thorough understand- India to offer studies and accepted
ing of the subject, extensive experience, high end instrumentation and qualified resource. E/L Studies. conducted by global
regulatory
authorities
Services Offered
• Extractables
• Leachables
• Ink & GumMigration
VIMTA provides customized protocol driven extractables and leachables testing services to
• Glass Delamination help ensure that your product is safe for the patient. Our scientific team is well versed with
• Elemental Analysis(ICH Q3D) applicable regulatory requirements, standards and guidelines such as PQRI, FDA, ISO, EMEA,
ICH, EP and USP,in addition to its decades of experience in analytical and physical chemistry.
• Toxicological Evaluation
• Genotoxic Impurities Our cGMP facilities offer a proven track record in carrying out studies of extractables and
leachables to detect ultra-trace levels of contaminants from materials in contact with drug
products or medicaldevices.

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 EXTRACTABLES LEACHABLES
• Evaluation of packaging materials including ‘Primary & Secondary’ components & manufacturing components.
• Customized studydesign. • Method development and validation for the quantification of leachables in the drug product.
• Controlled extraction study using different extraction techniques & solvents. • Monitoring of the unkowns using screening techniques.
• Qualitative and quantitative analysis of potential extractables. • Leachable monitoring throughout product shelf life.
Organic impurities - Non-volatiles, Semi volatiles, Volatiles • Correlation establishment of potential leachables & actual leachables.
Inorganic impurities –Anions & Elements • Toxicological evaluation.
• Optimization and validation of control extractable study for routine control of packaging material quality.

Packaging Material Experience PRODUCT EXPERIENCE

• Inhalations/Aerosols • Oral vaccines
• Rubber stoppers • Patches
• Ophthalmics • Topicals
• EPDM packaging • Films /Blister packs
• Injectables • Transdermal
• Gaskets &O-rings • Disposables (Bioprocess–singleuse)
• Large volumeparenterals • Oral suspensions
• Inhalation devices • Laminated tubes
• Suppository • Oral Solids
• Prefilled Syringes • HDPE / LDPE / PP / Plastic bags & containers
• Large volumecontainers • Tubing & Filters
• Implants • In-process manufacturingcomponents
• Resins • Glass vials, SyringesEtc.,
• Injectable bags /vials • Labels & Inks

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 GLASS DELAMINATION STUDY VALIDATIONS

Delamination is the process whereby thin layers of glass, described as either flakes or lamellae,
are detached from the inner surface of a glass container. The appearance of glass lamellae is the
most obvious visual indicator of structural instability which represents the final stage of a seriously
weakened glass surface. This is a serious quality issue and can result in a product recall.
The potential leachables from the extractable study of CCS are monitored in the drug product sample to
assess the suitability of the CCS for its intended purpose using validated methods.
The methods are developed and validated based on the ICH Q2(R1) and are used to monitor the potential
leachables through out the shelf life of the product.

• Degree of vial surface pitting The Validationcovers:

• pH andConductivity System Precision
• Particle morphology Linearity
• Elemental Analysis Accuracy
Specificity
Solution Stability
Method Precision

Intermediate Precision
Robustness
LOD & LOQ determination
LOD Precision
LOQ Precision
Range

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 INSTRUMENTATION IDENTIFICATION DATABASE

Vimta has created a database of compounds. These compounds have been categorized broadly as:
• LC-MS/MS • GC-FID –ECD & FPD
• GC-MS/MS • Atomic Absorption Spectrometry
• GC-MS Head Space and Purge & Trap • C,H,N,S Analyser • Plastics additives • Filter Residues
• HPLC with UV, Flame, RI, PDA detectors • FTIR • Tubing compounds • Ink migration
• HR-GC-MS (Auto Spec) • Particle SizeAnalyser • Residual Solvents • Gum & Adhesive
• ICP-MS • Automated Extraction Systems • Polymer Additives & Degradation compounds • Rubber ingredients &Impurities
• ICP -OES • SEM
• Ion Chromatograph with TCD & UVD • CE
The database is generated using authentic standards, retention time and mass spectrum and used
for the identification & confirmation of unknown peaks generated during the studies.

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 TOXICOLOGICAL EVALUATIONS BIOCOMPATIBILITY TESTING

VIMTAs in-house board certified toxicologists offers toxicological and safety evaluation of the VIMTA has over 2 decades of experience performing biocompatibility studies for the global medical
potential leachates identified during the controlled extraction study to aid in the selection of the device industries as per ISO – 10993 standards.
potential ones for leachable study design. This is a tedious task due to non-availability of the com-
In some specific cases, biocompatibility data needs to be generated on container closure systems.
pound profiles.
Among the risks to be considered are those arising from exposure to leachable substances from
container closure systems.
The toxicological evaluation is performed as per relevant ICH guidelines and strict compliance to
OECD GLP principles.

Vimta offers first pass screening using:

• ISO 10993-Part 3

TOPKAT Toxtree •
• ISO 10993-Part 4
ISO 10993-Part 5
• ISO 10993-Part 6
• ISO 10993-Part 10
• ISO 10993-Part 11
• In-vitro mutagenicity
• ISO 10993-Part 12
• In-vivo acute oraltoxicity
• ISO 10993-Part 18
• Cytotoxicity
• OECD 471: AMES testing (Mutagenicity)...

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 STABILITY PROGRAM TECHNICAL CONSULTATION

VIMTA is one of India’s largest providers of stability testing and storage services.
Multinational corporations in OTC, Rx, and Animal Health around the world trust our services.
We offer substantial cost-savings compared to investing in your own storage chambers, related space, manpower
and testing equipment thereby freeing up your resources for your core activities.
VIMTA's scientific team offers technical consultation at all phases of the project (pre & post)
The pre-project phase involves one-on-one discussion with the customer to understand the project
requirements. The studies are designed to meet the regulatory requirements and finalized in consultation
with the customer.
We support customers in data interpretation and evaluation for suitability of CCS with Drug products.

We conduct stability studies as per ICH guidelines and also offer customized stability programs.
Our state-of-the-art stability chambers, with close to ~4,50,000 Liters capacity, are equipped with advanced chiller
based technologies, backup systems, redundant power backup, alarms system, and automated temp / RH excursion
mobile phone notifications. All stability chambers are monitored 24x7.
The study reports include detailed conclusion which aid in submission and acceptance of the data.
Dedicated customer service
• We greatly value the importance of open and timely communications

• Dedicated project managementteam

Studies Conducted
• Clinical stability • Transport stability
• Developmental stability • Freeze thaw cyclingstability
• Follow-up stability • Photostability studies
• Registration stability • Customized stability programs

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 EXPERTISE

• 24/7 Operations

Speed to meet your internal or regulatory timelines • Optimized processes

•Proven efficiency of a strong technical team that can customize study • Cost Effective
design, develop protocols and conduct E&L studies.
• Scalable capacities.

Access to full capabilities of our company

Our expertise extends beyond E&L studies. We have vertically and
Compliant & reliable deliverables you can trust horizontally integrated CROservices.

•Excellent compliance track record with successful regulatory audits. • Toxicology assessments

• Multi discipline full service CRO with inter deployable resources • Stability studies
(people and equipment) and efficient operations • Genotoxic impurity studies
• Purpose built laboratory designed to minimize the risk of any cross • Method development andvalidations
contamination.
LCPMS, IC, LCMS/MS, GCMS/MS, HPLC, GC, UPLC, LCMS-TOF, HRGCMS
• Physical Characterication

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