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Pharmaglass ISO 17025 testing laboratory
Terakreditasi ISO/IEC 17025:2017

Laboratorium Pengujian In-House

Laboratorium terakreditasi ISO/IEC 17025 kami melakukan pengujian kualitas dan kepatuhan secara komprehensif pada semua produk kaca. Setiap batch diuji sebelum rilis untuk memastikan kesesuaian dengan standar farmakope, regulasi keamanan pangan, dan spesifikasi pelanggan.

ISO/IEC 17025:2017
Kompetensi Laboratorium Pengujian & Kalibrasi
USP / EP / JP
Instrumen standar USP/EP/JP
100%
Kepatuhan Regulasi

Jaminan Mutu

Setiap wadah kaca diuji secara ketat di laboratorium terakreditasi ISO 17025 kami untuk memastikan kepatuhan terhadap standar farmakope dan regulasi keamanan pangan sebelum rilis.

Hydrolytic Resistance Testing

Glass durability testing per USP <660> and EP 3.2.1 standards. Surface and powdered glass tests to classify hydrolytic resistance and ensure container-content compatibility.

USP <660> / EP 3.2.1

Thermal Shock Testing

Evaluates glass resistance to sudden temperature changes. Containers are subjected to controlled thermal differentials to verify structural integrity under processing and filling conditions.

ISO 7459 / ASTM C149

Dimensional Analysis

Precision measurement of all critical dimensions including bore diameter, wall thickness, height, weight, and capacity using calibrated optical and mechanical instruments.

ISO 8362 / ISO 9187

Internal Pressure Testing

Destructive and non-destructive pressure testing to determine burst strength and verify containers meet minimum pressure requirements for bottled and sealed applications.

ISO 7458 / ASTM C147

Chemical Resistance Testing

Extractable and leachable studies measuring heavy metals, arsenic release, and alkali content. Ensures glass formulation meets pharmacopeial limits for chemical durability.

USP <660> / EP 3.2.1

Surface Treatment Verification

Analysis of surface coatings, de-alkalization treatments, and decorative finishes. Verifies coating adhesion, uniformity, and long-term performance.

ISO 12775 / Internal SOP

Akreditasi

Terakreditasi ISO/IEC 17025:2017 untuk pengujian kaca farmasi dan food-grade, memastikan hasil yang valid secara teknis dan diakui internasional.

  • Pengujian ketahanan hidrolitik (USP <660>, EP 3.2.1)
  • Analisis dimensi dan pengukuran ketebalan dinding
  • Ketahanan tekanan internal dan kejut termal
  • Studi extractable dan leachable
  • Pengujian pelepasan logam berat dan arsenik
  • Analisis transmisi cahaya dan perlindungan UV
  • Adhesi coating dan ketahanan dekorasi
  • Pengujian integritas container closure (CCIT)

Peralatan Laboratorium

Instrumen mutakhir yang dikalibrasi sesuai standar internasional

Autotitrator
Hydrolytic resistance quantification
Muffle Furnace
Powdered glass test preparation
Coordinate Measuring Machine
Precision dimensional analysis
Burst Pressure Tester
Internal pressure qualification
Spectrophotometer
Light transmission and UV analysis
Thermal Shock Bath
Controlled temperature differential testing
Atomic Absorption Spectrometer
Heavy metals and elemental analysis
Coating Thickness Gauge
Surface treatment measurement

Program Jaminan Mutu

Sistem mutu komprehensif yang mencakup inspeksi bahan baku masuk, pengendalian proses, pengujian barang jadi, dan pengawasan pasca-pasar. Tim QA kami bekerja langsung dengan departemen mutu Anda untuk menyelaraskan spesifikasi, rencana sampling, dan persyaratan dokumentasi.

01

Sample Receipt

Incoming samples logged, labeled, and assigned unique test IDs

02

Test Planning

Test methods selected based on product type and customer specifications

03

Testing Execution

Tests performed by trained analysts using calibrated instruments

04

Data Review

Results reviewed against acceptance criteria by quality supervisor

05

Certificate Issuance

Certificate of Analysis (CoA) generated and released with batch

Pelajari Kapabilitas Laboratorium Kami

Laboratorium pengujian kami terakreditasi ISO/IEC 17025:2017 untuk pengujian kaca farmasi dan food-grade, menghasilkan hasil yang diakui secara internasional dan valid secara teknis.