::: SPK :::

Home > Reference >개념설계 실적

Kukje

Cephalosporin Manufacturing Facility
Seoul, South Korea

Brief
Kukje required a Cephalosporin manufacturing facility for the production of sterile & non sterile products in the forms of tablets, capsules, dry syrup, sterile injectables & freeze dried injectables.
The new facility replaces an existing redundant, outdated building & supplies local & international markets with numerous pharmaceutical broad spectrum antibiotic products.
The key objectives which the facility had to deliver were, compliance with latest KFDA, FDA, EU regulations, state of the art GMP design, increased production & segregation of Cephalosporin product from other existing manufacturing processes.

Cost
$25M

Areas
1F 1,900m²
2F 1,900m²
3F 1,900m²
4F 1,087m²
Total 6,787m²

Key Functional Areas
Sterile Powder Manufacturing (Grade A/B/C)
Sterile Freeze Dried Manufacturing (Grade
A/B/C)
Solid Dose Manufacturing (ISO8)
Primary & Secondary Packaging (ISO8)
Materials Air Locks MAL
Personnel Air Locks PAL
Warehousing (Controlled Environment)
QC/QA Laboratories
Administration Offices
Plant Rm - interstitial trafficable space

SPK Services
Project Management
Design Management
Architectural Concept Design
Process Engineering Concept Design
Mechanical Engineering Concept Design
Electrical & Data Engineering Concept Design

Project Outcomes
Cephalosporin production segregated from other product manufacturing.
Efficient & greatly improved material & personnel flows, increased flexibility & productivity.
Introduction of technologies to reduce dust generation & improve product quality & operators’ safety.
Innovative engineering principles for process & building services to ensure sterile environment, improve reliability & energy efficiency.
Process modelling of the production capacity & budget costing supporting Kukje implementation strategy.
Unique, yet functional facility design integrated with existing buildings & services on campus style manufacturing site.

Hanseo Pharm

Solid Dose Manufacturing Facility
Gyeonggi-do, South Korea

Brief
Hanseo Pharm required a new solid dose manufacturing facility for the production & packaging of pharmaceuticals.
The new facility enables the implementation of Hanseo’s 5 year plan to increase production capacity to 1,065 batches per year (100 to 300 Kg sizes), 569,400,000 tablets & 223,100,000 capsules.
The key objectives which the facility had to deliver were, compliance with latest KFDA, FDA, EU regulations, state of the art GMP design for solid dose manufacturing, accommodation of all personnel in one location & provision for future expansion.

Cost
$30M

Areas
GF 6,547m²
1F 3,608m²
Total 10,155m²

Key Functional Areas
Manufacturing (ISO 8 clean room)
Dispensaries & sampling (ISO 8 clean room)
Packaging (ISO 9 clean room)
Warehouse
Micro & Chemical Wet Labs
Animal Lab (PC2)
Office & staff amenities
Plant & Engineering area – interstitial space
Cafe & outdoor terrace
Dangerous goods store
External car parking & tennis court

Project Outcomes
Efficient & greatly improved material & personnel flows, increased flexibility & productivity.
Introduction of technologies to reduce dust generation & improve product quality & operators’ safety.
Innovative engineering principles for process & building services to improve reliability & energy efficiency.
Process modelling of the production capacity & budget costing with an implementation strategy for Hanseo to meet its 5 year plan.
Unique, yet functional facility design with

삼진제약 무균 파우더 및 앰플 생산 시설

Brief
기존 공장에서 생산하는 무균 파우더 주사제와 앰플 생산시설을 위한 전용 공장으로 2007년부터 개념설계를 수행하였다.
2008년에 완공하여, 안정적으로 생산공정을 유지하고 있다.

Areas
1층 : 550평 (GMP 시설)
2층 : 550평 (연구소)

Class A,B,C,D (EUGMP) 를 기준으로 설계

Cost
약 80억

SPK Service
- 개념설계
- 상세설계 검토
- Design Qualificationt
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Process Validation